Safety, Immunogenicity, and Effectiveness of COVID-19 Vaccines for Pregnant Persons: A Living Systematic Review and Meta-analysis

Summary tables

Total number of full-extracted studies: 249 (from 251 collected studies)

Maternal outcomes (Pregnancy related outcomes)

Comparative measure

Table 1: Study characteristics and main results from studies that assessed maternal-pregnancy outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Exposed study population	Vaccine product (Dose)b	Comparator	Trimester of vaccine exposurec	Time since vaccination until outcome measure	Outcome	Primary result
Mensah, A. (Oct, 2023)	United Kingdom (EUR)	Case control	182,477	General pregnant population vaccinated	AZDi	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.98 [0.64;1.5]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.97 [0.71;1.32]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	1st Tr	Nonspecified	Stillbirth	Adj OR:1.04 [0.8;1.34]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	2nd Tr	Nonspecified	Stillbirth	Adj OR:0.99 [0.82;1.2]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	3rd Tr	Nonspecified	Stillbirth	Adj OR:0.93 [0.75;1.17]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.9 [0.76;1.07]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.83 [0.67;1.04]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.85 [0.69;1.05]
Kharbanda, E.O (Oct, 2021)	United States (AMR)	Case control	21,267	General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:1.02 [0.96;1.08]
Faherty, E (Mar, 2024)	United States (AMR)	Case control	18,863	General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	RR:0.53 [0.34;0.78]
Kharbanda, EO (May, 2023)	United States (AMR)	Case control	11,648	General pregnant population vaccinated	Mod	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:0.93 [0.81;1.07]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:0.94 [0.86;1.03]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 42 Days	Miscarriage / Abortion	Adj VE:0.97 [0.9;1.05]
				General pregnant population vaccinated	Mod Pfz J&J	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:0.94 [0.82;1.07]
				General pregnant population vaccinated	Mod Pfz J&J	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:0.93 [0.83;1.05]
				General pregnant population vaccinated	Mod Pfz J&J	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 42 Days	Miscarriage / Abortion	Adj RR:1 [0.89;1.11]
				General pregnant population vaccinated	Mod Pfz J&J	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 42 Days	Miscarriage / Abortion	Adj RR:0.94 [0.85;1.03]
				General pregnant population vaccinated	Mod Pfz J&J	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 42 Days	Miscarriage / Abortion	Adj VE:0.96 [0.89;1.04]
				General pregnant population vaccinated	Nonspecified	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 42 Days	Miscarriage / Abortion	Adj OR:0.99 [0.89;1.11]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:0.95 [0.84;1.07]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 42 Days	Miscarriage / Abortion	Adj OR:0.95 [0.86;1.05]
				General pregnant population vaccinated; Any COVID-19 vaccine booster (including a second dose of Ad26.COV.2.S [Janssen] or a second or third dose of an mRNA COVID-19 vaccine after Ad26.COV.2.S or a fourth or fifth mRNA COVID-19 vaccine dose)	Mod Pfz J&J	Versus other COVID-19 vaccine exposure	1st Tr; 2nd Tr	Mean: 28 Days	Miscarriage / Abortion	Adj OR:0.94 [0.86;1.02]
Magnus, M.C. (Oct, 2021)	Norway (EUR)	Case control	1,003	General pregnant population vaccinated; Health workers	AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.84 [0.48;1.48]
				General pregnant population vaccinated; Health workers	Mod	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.84 [0.56;1.25]
				General pregnant population vaccinated; Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 3 Weeks	Miscarriage / Abortion	Adj OR:0.99 [0.73;1.33]
				General pregnant population vaccinated; Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.78 [0.65;0.94]
				General pregnant population vaccinated; Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.94 [0.73;1.21]
				General pregnant population vaccinated; Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.88 [0.67;1.17]
				General pregnant population vaccinated; Health workers	Pfz	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.8 [0.67;0.96]
				Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 3 Weeks	Miscarriage / Abortion	Adj OR:1.01 [0.67;1.51]
				Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.87 [0.6;1.28]
				Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.99 [0.67;1.46]
				Health workers	Mod Pfz AZD	Unvaccinated	1st Tr	Mean: 5 Weeks	Miscarriage / Abortion	Adj OR:0.88 [0.62;1.23]
Denoble, A (Jun, 2024)	United States (AMR)	Case control	429	General pregnant population vaccinated	Mod	Unvaccinated	Global	Nonspecified	Stillbirth	OR:1.07 [0.68;1.68]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1 [0.62;1.62]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	OR:1.17 [0.75;1.81]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	OR:0.93 [0.77;1.13]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1.17 [0.75;1.83]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.98 [0.81;1.17]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	OR:1.1 [0.69;1.75]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1.16 [0.74;1.83]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Stillbirth	OR:0.92 [0.63;1.33]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1 [0.69;1.43]
Velez, M. (Nov, 2023)	Canada (AMR)	Comparative Cohort	43,981	General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj HR:0.99 [0.93;1.06]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj HR:1 [0.93;1.08]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj HR:0.99 [0.93;1.42]
Fell, D.B. (Aug, 2022)	Canada (AMR)	Comparative Cohort	43,099	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Nonspecified	Stillbirth	Adj HR:0.65 [0.51;0.84]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Nonspecified	Stillbirth	HR:0.65 [0.51;0.82]
Fell, DB (Jul, 2023)	Canada (AMR)	Comparative Cohort	32,689	General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Caesarean delivery	Adj HR:0.9 [0.87;0.94]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Chorioamnionitis	Adj HR:0.67 [0.49;0.9]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Emergency caesarean	Adj HR:0.9 [0.85;0.96]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Hypertensive disorders of pregnancy	Adj HR:1.03 [0.94;1.14]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Placental abruption	Adj HR:0.84 [0.7;1.02]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Postpartum haemorrhage	Adj HR:1.01 [0.89;1.16]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Stillbirth	Adj HR:0.56 [0.39;0.81]
Magnus, M.C. (Mar, 2022)	Sweden, Norway (EUR)	Comparative Cohort	28,506	General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Stillbirth	Adj HR:0.86 [0.63;1.17]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Stillbirth	HR:0.77 [0.57;1.05]
Fell, DB (Mar, 2022)	Canada (AMR)	Comparative Cohort	22,660	General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj RR:0.97 [0.94;1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Chorioamnionitis	Adj RR:1.2 [0.9;1.59]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Emergency caesarean	Adj RR:0.91 [0.87;0.96]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj RR:0.9 [0.81;1]
				General pregnant population vaccinated	Mod Pfz	Vaccine after pregnancy	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj RR:0.92 [0.89;0.95]
				General pregnant population vaccinated	Mod Pfz	Vaccine after pregnancy	2nd Tr; 3rd Tr	Nonspecified	Chorioamnionitis	Adj RR:0.92 [0.7;1.21]
				General pregnant population vaccinated	Mod Pfz	Vaccine after pregnancy	2nd Tr; 3rd Tr	Nonspecified	Emergency caesarean	Adj RR:0.89 [0.84;0.94]
				General pregnant population vaccinated	Mod Pfz	Vaccine after pregnancy	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj RR:0.91 [0.82;1.02]
Changizi, N. (Sep, 2023)	Iran;Islamic Rep. ()	Comparative Cohort	19,922	General pregnant population vaccinated	AZD SIN SpV Other	Unvaccinated	Global	Nonspecified	Caesarean delivery	OR:0.856 [0.751;0.977]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Stillbirth	OR:0.097 [0.026;0.252]
Calvert, C (Oct, 2022)	United Kingdom (EUR)	Comparative Cohort	18,780	General pregnant population vaccinated	Mod	Unvaccinated; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Ectopic pregnancy	Adj OR:2.07 [0.98;4.38]
				General pregnant population vaccinated	Mod	Unvaccinated; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj RR:1.07 [0.87;1.33]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Ectopic pregnancy	Adj OR:1.13 [0.92;1.38]
				General pregnant population vaccinated	Pfz	Unvaccinated; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Ectopic pregnancy	Adj OR:1.11 [0.87;1.42]
				General pregnant population vaccinated	Pfz	Unvaccinated; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj OR:1 [0.93;1.08]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	AZDi	Unvaccinated; Non-previous SARS-CoV-2 infection; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj OR:1.17 [1.03;1.34]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	AZDi	Unvaccinated; Non-previous SARS-CoV-2 infection; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Ectopic pregnancy	Adj OR:1.16 [0.74;1.83]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZDi	Unvaccinated; Non-previous SARS-CoV-2 infection; Pre-pandemic controls	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj OR:1.02 [0.96;1.09]
Hatami, D (Mar, 2024)	Iran;Islamic Rep. ()	Comparative Cohort	17,485	General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Nonspecified	Fetal growth retardation (or restriction)	OR:1.29 [0.89;1.86]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:1.37 [0.93;2.02]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Nonspecified	Stillbirth	OR:1.14 [0.61;2.14]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Nonspecified	Stillbirth	Adj OR:1.09 [0.58;2.06]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Nonspecified	Fetal growth retardation (or restriction)	OR:1.01 [0.88;1.17]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:1 [0.86;1.17]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Nonspecified	Stillbirth	RR:0.85 [0.66;1.1]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Nonspecified	Stillbirth	Adj OR:0.74 [0.56;0.98]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Nonspecified	Fetal growth retardation (or restriction)	OR:0.98 [0.81;1.18]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:1.05 [0.86;1.28]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Nonspecified	Stillbirth	OR:0.36 [0.22;0.59]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Nonspecified	Stillbirth	Adj OR:0.25 [0.13;0.46]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Fetal growth retardation (or restriction)	OR:1.02 [0.86;1.22]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Fetal growth retardation (or restriction)	OR:1.02 [0.88;1.17]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:1.07 [0.88;1.29]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:1.03 [0.88;1.2]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Gestational diabetes	PR:NA [NA;NA]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Preeclampsia/eclampsia	PR:NA [NA;NA]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Stillbirth	OR:0.91 [0.67;1.23]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Stillbirth	OR:0.57 [0.42;0.77]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.74 [0.53;1.04]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.5 [0.36;0.7]
Hui, L (May, 2023)	Australia (WPR)	Comparative Cohort	17,365	General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Nonspecified	Elective caesarean	Adj OR:0.9 [0.81;0.99]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr; 2nd Tr	Nonspecified	Stillbirth	Adj OR:0.17 [0.07;0.44]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	In labor caesarean	Adj OR:1.07 [1.07;1.21]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Instrumental (Vacuum/forceps) delivery	Adj OR:1.08 [0.96;1.21]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Postpartum haemorrhage	Adj OR:0.97 [0.83;1.13]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:0.18 [0.09;0.37]
Lindsay L. (Aug, 2023)	United Kingdom (EUR)	Comparative Cohort	11,379	General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Antenatal bleeding	Adj OR:1.04 [0.99;1.09]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Antenatal bleeding	Adj OR:1.09 [1.04;1.14]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:0.89 [0.8;0.99]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:0.99 [0.9;1.1]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1.08 [0.68;1.7]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1.03 [0.63;1.68]
Gwak, E (Oct, 2023)	Korea;Rep. (WPR)	Comparative Cohort	5,284	General pregnant population vaccinated	AZDi	Versus other COVID-19 vaccine exposure	1st Tr	Nonspecified	Miscarriage / Abortion	Adj RR:0.91 [0.75;1.11]
				General pregnant population vaccinated	J&J	Versus other COVID-19 vaccine exposure	1st Tr	Nonspecified	Miscarriage / Abortion	Adj RR:0.93 [0.69;1.23]
				General pregnant population vaccinated	Mod Pfz J&J AZDi	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj RR:1.02 [0.96;1.08]
Peretz-Machluf, R (Apr, 2022)	Israel (EUR)	Comparative Cohort	3,240	General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj OR:0.86 [0.64;1.14]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Emergency caesarean	Adj OR:0.78 [0.57;1.07]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:1.3 [0.7;2.42]
Feijter, M (Jul, 2023)	Netherlands (EUR)	Comparative Cohort	3,202	General pregnant population vaccinated	Nonspecified	Unvaccinated	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj HR:1.29 [0.93;1.74]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Nonspecified	preterm labor	Adj HR:0.93 [0.59;1.45]
Feijter, M. (Nov, 2023)	Netherlands (EUR)	Comparative Cohort	3,202	General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj HR:1.4 [1.04;1.89]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	HR:1.49 [1.11;1.99]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj HR:1.32 [0.91;1.67]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	Adj HR:1.29 [0.93;1.74]
Dick, A (Apr, 2022)	Israel (EUR)	Comparative Cohort	3,139	General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj OR:1.04 [0.75;1.46]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:3.88 [2.41;6.25]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj OR:1.04 [0.75;1.45]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:3.34 [2.07;5.39]
Villar, J. (Jan, 2023)	NigeriaMexico, Japan, Italy, Israel, Indonesia, France, Egypt;Arab Rep., Brazil, Argentina (EUR WPR AMR AFR SEAR)	Comparative Cohort	2,886	General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Antenatal bleeding	RR:1.01 [0.76;1.35]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Caesarean delivery	RR:0.98 [0.9;1.07]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Gestational hypertension	RR:1.22 [0.9;1.64]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Maternal death	RR:0.2 [0.02;1.97]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Pathways to preterm birth	RR:0.82 [0.59;1.14]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Preeclampsia/eclampsia	RR:1.02 [0.73;1.42]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Prelabour rupture of membranes	RR:0.96 [0.84;1.1]
McClymont E. (Oct, 2023)	Canada (AMR)	Comparative Cohort	2,868	General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Nonspecified	Caesarean delivery	OR:0.96 [0.85;1.09]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Nonspecified	Gestational diabetes	OR:1.04 [0.83;1.32]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Nonspecified	Hypertensive disorders of pregnancy	OR:1.08 [0.86;1.36]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Nonspecified	Miscarriage / Abortion	OR:2.62 [0.86;10.67]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Nonspecified	Stillbirth	OR:NA [0.53;NA]
Dick, A (Feb, 2022)	Israel (EUR)	Comparative Cohort	2,305	General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Nonspecified	Caesarean delivery	Adj OR:1.05 [0.85;1.3]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Nonspecified	Gestational diabetes	Adj OR:1.21 [0.93;1.58]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:0.71 [0.33;1.54]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:1.11 [0.71;1.74]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Nonspecified	Stillbirth	Adj OR:1.12 [0.52;2.38]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj OR:0.94 [0.79;1.11]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Gestational diabetes	Adj OR:1.1 [0.9;1.3]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:0.82 [0.48;1.38]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:1.2 [0.85;1.66]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Stillbirth	Adj OR:0.78 [0.42;1.44]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Nonspecified	Caesarean delivery	Adj OR:0.88 [0.72;1.07]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Nonspecified	Gestational diabetes	Adj OR:0.99 [0.77;1.27]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:0.83 [0.45;1.55]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:1.22 [0.83;1.78]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Nonspecified	Stillbirth	Adj OR:0.25 [0.08;0.82]
Mansour, O (Feb, 2023)	United Kingdom, Canada, United States (EUR AMR)	Comparative Cohort	2,133	General pregnant population vaccinated	Mod	Versus other COVID-19 vaccine exposure	1st Tr	Nonspecified	Miscarriage / Abortion	Adj HR:1.49 [0.73;3.04]
				General pregnant population vaccinated	Mod	Versus other COVID-19 vaccine exposure	1st Tr	Nonspecified	Miscarriage / Abortion	HR:1.99 [1.08;3.7]
Vuong, L.N. (May, 2022)	Vietnam (WPR)	Comparative Cohort	954	General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Nonspecified	Gestational diabetes	RR:4.3 [0.5;36.65]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Nonspecified	Oligohydramnios	RR:1.07 [0.51;2.26]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Nonspecified	Polyhydramnios	RR:1.41 [0.74;2.71]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Nonspecified	Preeclampsia/eclampsia	RR:4.3 [0.5;36.65]
Citu, IM (Mar, 2022)	Romania (EUR)	Comparative Cohort	927	General pregnant population vaccinated	Mod	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj OR:1.02 [0.89;1.08]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj OR:0.91 [0.69;1.08]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj OR:0.94 [0.66;1.05]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj OR:0.77 [0.6;1.01]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Nonspecified	Miscarriage / Abortion	Adj OR:1.04 [0.91;1.12]
Wainstock, T (Sep, 2021)	Israel (EUR)	Comparative Cohort	913	General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj OR:0.93 [0.75;1.16]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	OR:1.14 [0.93;1.39]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	OR:1.4 [0.95;2.06]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:1.13 [0.78;1.62]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Instrumental (Vacuum/forceps) delivery	Adj OR:0.99 [0.63;1.57]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Meconium stained amniotic fluid	Adj OR:0.52 [0.32;0.83]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Non-reassuring fetal status	Adj OR:0.7 [0.48;1.01]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Oligohydramnios	Adj OR:0.84 [0.52;1.4]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Polyhydramnios	Adj OR:0.77 [0.29;2.03]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:1.46 [0.63;3.38]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Nonspecified	Hypertensive disorders of pregnancy	OR:1.07 [0.74;1.53]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Nonspecified	Hypertensive disorders of pregnancy	OR:1.69 [0.92;3.11]
Rottenstreich, M (Oct, 2021)	Israel (EUR)	Comparative Cohort	712	General pregnant population vaccinated	Pfz	Unvaccinated	3rd Tr	Nonspecified	Composite adverse maternal outcome	Adj OR:0.8 [0.61;1.03]
Ibroci, E. (Dec, 2022)	United States (AMR)	Comparative Cohort	250	General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	1st Tr	Nonspecified	Caesarean delivery	Adj RR:0.7 [0.4;1.4]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	2nd Tr	Nonspecified	Caesarean delivery	Adj RR:0.9 [0.6;1.3]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	3rd Tr	Nonspecified	Caesarean delivery	Adj RR:0.8 [0.5;1.1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	Global	Nonspecified	Caesarean delivery	Adj RR:0.8 [0.6;1.1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	Global	Nonspecified	Caesarean delivery	RR:1.1 [0.9;1.4]
Dizdar, M. (Jan, 2024)	Turkey (EUR)	Comparative Cohort	212	General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Nonspecified	Emergency caesarean	Adj OR:0.95 [0.68;1.36]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Nonspecified	Preeclampsia/eclampsia	Adj OR:1.85 [0.46;6.45]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Nonspecified	Stillbirth	Adj OR:1.44 [0;9.29]
Blakeway, H (Aug, 2021)	United Kingdom (EUR)	Comparative Cohort	133	General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	Adj OR:0.86 [0.56;1.31]
				General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Instrumental (Vacuum/forceps) delivery	Adj OR:1.59 [0.9;2.8]
				General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	Unvaccinated	2nd Tr; 3rd Tr	Nonspecified	Postpartum haemorrhage	Adj OR:1.09 [0.56;2.12]
Eid, J. (Jul, 2022)	United States (AMR)	Comparative Cohort	125	Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Caesarean delivery	Adj OR:1.14 [0.62;2.09]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Chorioamnionitis	Adj OR:0.54 [0.08;2.07]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:0.59 [0.16;1.63]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Gestational diabetes	Adj OR:1.5 [0.21;6.89]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:0.71 [0.27;1.62]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Postpartum haemorrhage	Adj OR:3.23 [1;9.67]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Prelabour rupture of membranes	Adj OR:0.44 [0.02;2.51]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Stillbirth	Adj OR:1.41 [0.07;11.5]
Li, M. (Dec, 2022)	China (WPR)	Comparative Cohort	93	General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	Unvaccinated	1st Tr	Nonspecified	Prelabour rupture of membranes	OR:2.693 [1.156;6.023]
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	Unvaccinated	1st Tr	Nonspecified	Prelabour rupture of membranes	Adj OR:2.407 [0.932;6.216]
Shanes, E.D. (Aug, 2021)	United States (AMR)	Comparative Cohort	84	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Non-previous SARS-CoV-2 infection	Non-specified	Nonspecified	Decidual arteriopathy	Adj OR:0.75 [0.3;1.9]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Non-previous SARS-CoV-2 infection	Non-specified	Nonspecified	Fetal vascular malperfusion	Adj OR:0.85 [0.27;2.7]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Non-previous SARS-CoV-2 infection	Non-specified	Nonspecified	High-grade chronic villitis	Adj OR:0.31 [0.1;0.97]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Non-previous SARS-CoV-2 infection	Non-specified	Nonspecified	Low-grade chronic villitis	Adj OR:1.6 [0.62;4.2]
Hillson, K. (Oct, 2021)	South Africa, Brazil, United Kingdom (EUR AMR AFR)	Comparative Cohort	72	General pregnant population vaccinated	AZD	Another vaccine	1st Tr	Nonspecified	Miscarriage / Abortion	Adj RR:0.84 [0.24;2.9]
Boelig R. (Mar, 2022)	United States (AMR)	Comparative Cohort	49	General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Nonspecified	Maternal vascular malperfusion	Adj OR:0.61 [0.22;1.68]
Ki Hoon, A (Aug, 2022)	Korea;Rep. (WPR)	Comparative Cohort Cross-sectional	13,240	Non-specified	AZD		Global	Nonspecified	Hypertensive disorders of pregnancy
Peretz-Machluf, R (Jan, 2024)	Israel (EUR)	Cross-sectional	223	General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Fetal growth retardation (or restriction)	Adj OR:0.63 [0.127;3.1]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	Global	Nonspecified	Hypertensive disorders of pregnancy	Adj OR:3.13 [0.451;21.7]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	Non-specified	Nonspecified	Emergency caesarean	Adj OR:0.21 [0.048;0.926]
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Non-Comparative measure

Analysis unit: Persons

Table 2: Study characteristics and main results from studies that assessed maternal-pregnancy outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Exposed study population	Vaccine product (Dose)b	Trimester of vaccine exposurec	Time since vaccination until outcome measure	Outcome	Primary result
Jorgensen S. (Oct, 2023)	Canada (AMR)	Comparative Cohort	85,670	General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Caesarean delivery	27884/85670 (32.55%)
Stock, S. (Jan, 2021)	United Kingdom (EUR)	Comparative Cohort	18,399	General pregnant population vaccinated	Mod Pfz AZD	Global	Nonspecified	Stillbirth	11/2364 (0.47%)
Hui, L (May, 2023)	Australia (WPR)	Comparative Cohort	17,365	General pregnant population vaccinated	Pfz	Global	Nonspecified	Caesarean delivery	3412/9682 (35.24%)
Kachikis, A (Aug, 2021)	United States (AMR)	Comparative Cohort	7,809	General pregnant population vaccinated; Health workers	Mod Pfz	Global	Nonspecified	Miscarriage / Abortion	49/7809 (0.63%)
Goldshtein, I (Jul, 2021)	Israel (EUR)	Comparative Cohort	7,530	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Mean: 28 Days	Fetal growth retardation (or restriction)	36/7530 (0.48%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Mean: 28 Days	Maternal death	0/7530 (0.00%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Mean: 28 Days	Obstetric pulmonary embolism	0/7530 (0.00%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Mean: 28 Days	Preeclampsia/eclampsia	20/7530 (0.27%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Mean: 28 Days	Stillbirth	1/7530 (0.01%)
Darwin, K (Aug, 2023)	United States (AMR)	Comparative Cohort	5,749	General pregnant population vaccinated	Pfz	Non-specified	Nonspecified	Caesarean delivery	1119/3462 (32.32%)
Sadarangani, M. (Feb, 2022)	Canada (AMR)	Comparative Cohort	5,597	General pregnant population vaccinated	Mod	Global	Mean: 7 Days	Antenatal bleeding	11/2183 (0.50%)
				General pregnant population vaccinated	Mod	Global	Mean: 7 Days	Hypertensive disorders of pregnancy	2/2183 (0.09%)
				General pregnant population vaccinated	Mod	Global	Mean: 7 Days	Miscarriage/still birth	32/2183 (1.47%)
				General pregnant population vaccinated	Mod	Global	Mean: 7 Days	Pathways to preterm birth	2/2183 (0.09%)
				General pregnant population vaccinated	Mod Pfz	Global	Mean: 7 Days	Antenatal bleeding	21/5597 (0.38%)
				General pregnant population vaccinated	Mod Pfz	Global	Mean: 7 Days	Hypertensive disorders of pregnancy	6/5597 (0.11%)
				General pregnant population vaccinated	Mod Pfz	Global	Mean: 7 Days	Miscarriage/still birth	81/5597 (1.45%)
				General pregnant population vaccinated	Mod Pfz	Global	Mean: 7 Days	Pathways to preterm birth	3/5597 (0.05%)
				General pregnant population vaccinated	Pfz	Global	Mean: 7 Days	Antenatal bleeding	10/3414 (0.29%)
				General pregnant population vaccinated	Pfz	Global	Mean: 7 Days	Hypertensive disorders of pregnancy	4/3414 (0.12%)
				General pregnant population vaccinated	Pfz	Global	Mean: 7 Days	Miscarriage/still birth	51/3414 (1.49%)
				General pregnant population vaccinated	Pfz	Global	Mean: 7 Days	Pathways to preterm birth	1/3414 (0.03%)
Saban A. (-)	Israel (EUR)	Comparative Cohort	3,379	General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Prelabour rupture of membranes	508/3379 (15.03%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	Non-specified	Nonspecified	Placental abruption	13/3379 (0.38%)
Peretz-Machluf, R (Apr, 2022)	Israel (EUR)	Comparative Cohort	3,240	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Gestational diabetes	446/3240 (13.77%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Gestational hypertension	65/3240 (2.01%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Preeclampsia/eclampsia	42/3240 (1.30%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Prelabour rupture of membranes	103/3240 (3.18%)
Dick, A (Apr, 2022)	Israel (EUR)	Comparative Cohort	3,139	General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Gestational diabetes	36/294 (12.24%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	0/294 (0.00%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Stillbirth	0/294 (0.00%)
Mcclymont, E. (Feb, 2023)	Canada (AMR)	Comparative Cohort	3,050	General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Fetal growth retardation (or restriction)	110/3050 (3.61%)
Villar, J. (Jan, 2023)	NigeriaMexico, Japan, Italy, Israel, Indonesia, France, Egypt;Arab Rep., Brazil, Argentina (EUR WPR AMR AFR SEAR)	Comparative Cohort	2,886	General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Hypertensive disorders of pregnancy	211/2308 (9.14%)
Mansour, O (Feb, 2023)	United Kingdom, Canada, United States (EUR AMR)	Comparative Cohort	2,133	General pregnant population vaccinated	Mod Pfz	1st Tr	Nonspecified	Miscarriage / Abortion	44/2133 (2.06%)
Rottenstreich, M. (Sep, 2022)	Israel (EUR)	Comparative Cohort	1,720	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Caesarean delivery	105/626 (16.77%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Chorioamnionitis	13/626 (2.08%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Elective caesarean	63/626 (10.06%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Home/car delivery	10/626 (1.60%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	In labor caesarean	32/626 (5.11%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Instrumental (Vacuum/forceps) delivery	43/626 (6.87%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Maternal ICU admission	1/626 (0.16%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Placental abruption	9/626 (1.44%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Postpartum haemorrhage	41/626 (6.55%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Nonspecified	Stillbirth	24/626 (3.83%)
Santos, J (Apr, 2024)	United States (AMR)	Comparative Cohort	1,098	General pregnant population vaccinated	Mod Pfz J&J	1st Tr	Nonspecified	Stillbirth	1/319 (0.31%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Stillbirth	2/1176 (0.17%)
Vuong, L.N. (May, 2022)	Vietnam (WPR)	Comparative Cohort	954	General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Maternal death	0/513 (0.00%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Maternal ICU admission	2/513 (0.39%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Stillbirth	1/513 (0.19%)
Kugelman, N. (Nov, 2022)	Israel (EUR)	Comparative Cohort	930	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	222/930 (23.87%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Fetal growth retardation (or restriction)	40/930 (4.30%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Instrumental (Vacuum/forceps) delivery	36/930 (3.87%)
				General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Stillbirth	2/930 (0.22%)
Citu, IM (Mar, 2022)	Romania (EUR)	Comparative Cohort	927	General pregnant population vaccinated	Mod Pfz	1st Tr	Nonspecified	Miscarriage / Abortion	124/927 (13.38%)
Wainstock, T (Sep, 2021)	Israel (EUR)	Comparative Cohort	913	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Nonspecified	Placental abruption	3/913 (0.33%)
Sakhvidi, M.Z. (Sep, 2023)	Iran;Islamic Rep. ()	Comparative Cohort	720	General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	256/558 (45.88%)
				General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	75/162 (46.30%)
Rottenstreich, M (Oct, 2021)	Israel (EUR)	Comparative Cohort	712	General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Blood products transfusion	4/712 (0.56%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Caesarean delivery	111/712 (15.59%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Elective caesarean	82/712 (11.52%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	In labour caesarean	17/712 (2.39%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Instrumental (Vacuum/forceps) delivery	23/712 (3.23%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Maternal ICU admission	0/712 (0.00%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Placental abruption	8/712 (1.12%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Postpartum haemorrhage	52/712 (7.30%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Prolonged hospital stay	11/712 (1.54%)
				General pregnant population vaccinated	Pfz	3rd Tr	Nonspecified	Stillbirth	5/712 (0.70%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Nonspecified	Chorioamnionitis	14/712 (1.97%)
Süt H. (Jun, 2023)	Turkey (EUR)	Comparative Cohort	236	General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Fetal growth retardation (or restriction)	7/236 (2.97%)
				General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Gestational diabetes	9/236 (3.81%)
				General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Preeclampsia/eclampsia	5/236 (2.12%)
Cahen-Peretz, A. (Jan, 2023)	Israel (EUR)	Comparative Cohort	213	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Caesarean delivery	13/86 (15.12%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Gestational diabetes	2/86 (2.33%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	5/86 (5.81%)
Dizdar, M. (Jan, 2024)	Turkey (EUR)	Comparative Cohort	212	General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Chorioamnionitis	1/212 (0.47%)
				General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Gestational diabetes	23/212 (10.85%)
				General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Gestational hypertension	2/212 (0.94%)
				General pregnant population vaccinated	Pfz CRV	Global	Nonspecified	Preeclampsia/eclampsia	10/212 (4.72%)
Bleicher, I (Sep, 2021)	Israel (EUR)	Comparative Cohort	202	General pregnant population vaccinated	Pfz	Global	Nonspecified	Antenatal bleeding	4/202 (1.98%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Composite pregnancy complications (defined as having one or more of any of the following: vaginal bleeding at any point of gestation following the vaccination, first or second trimester pregnancy losses, fetal growth restriction, gestational diabetes or diabetes mellitus, hypertensive disease, fetal malformations observed on first or second anatomy scan (usually performed between 14 and 16 and 20-24 weeks of gesta- tion, respectively), premature labor and premature contractions)	32/202 (15.84%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Fetal growth retardation (or restriction)	3/202 (1.49%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	0/202 (0.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Pregnancy loss 14-28 gestational weeks	0/202 (0.00%)
				General pregnant population vaccinated	Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	2/202 (0.99%)
Citu, IM (Feb, 2022)	Romania (EUR)	Comparative Cohort	173	General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Abnormal presentation	7/173 (4.05%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Caesarean delivery	20/173 (11.56%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Endometritis	4/173 (2.31%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Gestational diabetes	12/173 (6.94%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	9/173 (5.20%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Instrumental (Vacuum/forceps) delivery	7/173 (4.05%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Oligohydramnios	6/173 (3.47%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Placental abruption	5/173 (2.89%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Polyhydramnios	4/173 (2.31%)
				General pregnant population vaccinated	Pfz J&J	3rd Tr	Nonspecified	Postpartum haemorrhage	3/173 (1.73%)
Smithgall, M (Nov, 2022)	United States (AMR)	Comparative Cohort	164	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-specified	Nonspecified	Caesarean delivery	76/164 (46.34%)
Toussia-Cohen, S. (Aug, 2022)	Israel (EUR)	Comparative Cohort	162	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	2nd Tr; 3rd Tr	Nonspecified	Antenatal bleeding	0/84 (0.00%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	2nd Tr; 3rd Tr	Nonspecified	Prelabour rupture of membranes	0/84 (0.00%)
Theiler, R N (Aug, 2021)	United States (AMR)	Comparative Cohort	140	General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Caesarean delivery	44/140 (31.43%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Gestational hypertension	19/140 (13.57%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Hypertensive disorders of pregnancy	20/140 (14.29%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Maternal death	0/140 (0.00%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Postpartum haemorrhage	1/140 (0.71%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Preeclampsia/eclampsia	1/140 (0.71%)
				General pregnant population vaccinated	Mod Pfz J&J	Global	Nonspecified	Stillbirth	0/140 (0.00%)
Moro, P (Apr, 2024)	United States (AMR)	Comparative Cohort	136	General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Gestational diabetes	4/136 (2.94%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Miscarriage / Abortion	12/136 (8.82%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Postpartum haemorrhage	5/136 (3.68%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Preeclampsia/eclampsia	5/136 (3.68%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Stillbirth	1/136 (0.74%)
Blakeway, H (Aug, 2021)	United Kingdom (EUR)	Comparative Cohort	133	General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	2nd Tr; 3rd Tr	Nonspecified	Placental abruption	0/133 (0.00%)
				General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	2nd Tr; 3rd Tr	Nonspecified	Stillbirth	0/133 (0.00%)
Tripathy, G (Jul, 2023)	India (SEAR)	Comparative Cohort	127	General pregnant population vaccinated	AZDi BBV	1st Tr	Nonspecified	Gestational diabetes	0/27 (0.00%)
				General pregnant population vaccinated	AZDi BBV	1st Tr	Nonspecified	Gestational hypertension	2/27 (7.41%)
				General pregnant population vaccinated	AZDi BBV	1st Tr	Nonspecified	Prelabour rupture of membranes	4/27 (14.81%)
				General pregnant population vaccinated	AZDi BBV	2nd Tr	Nonspecified	Gestational diabetes	1/51 (1.96%)
				General pregnant population vaccinated	AZDi BBV	2nd Tr	Nonspecified	Gestational hypertension	5/51 (9.80%)
				General pregnant population vaccinated	AZDi BBV	2nd Tr	Nonspecified	Prelabour rupture of membranes	3/51 (5.88%)
				General pregnant population vaccinated	AZDi BBV	3rd Tr	Nonspecified	Gestational diabetes	3/49 (6.12%)
				General pregnant population vaccinated	AZDi BBV	3rd Tr	Nonspecified	Gestational hypertension	3/49 (6.12%)
				General pregnant population vaccinated	AZDi BBV	3rd Tr	Nonspecified	Prelabour rupture of membranes	4/49 (8.16%)
				General pregnant population vaccinated	AZDi BBV	Global	Nonspecified	Caesarean delivery	79/127 (62.20%)
				General pregnant population vaccinated	AZDi BBV	Global	Nonspecified	Gestational diabetes	4/127 (3.15%)
				General pregnant population vaccinated	AZDi BBV	Global	Nonspecified	Gestational hypertension	10/127 (7.87%)
				General pregnant population vaccinated	AZDi BBV	Global	Nonspecified	Prelabour rupture of membranes	11/127 (8.66%)
				General pregnant population vaccinated	AZDi BBV	Global	Nonspecified	Stillbirth	2/127 (1.57%)
Eid, J. (Jul, 2022)	United States (AMR)	Comparative Cohort	125	Previous SARS-CoV-2 infection	Mod Pfz J&J	Global	Nonspecified	Medically indicated preterm delivery due to worsening COVID-19	0/72 (0.00%)
Ling, L. (Aug, 2023)	China (WPR)	Comparative Cohort	105	General pregnant population vaccinated	SIN	1st Tr	Nonspecified	Fetal growth retardation (or restriction)	3/105 (2.86%)
				General pregnant population vaccinated	SIN	1st Tr	Nonspecified	Maternal ICU admission	2/105 (1.90%)
				General pregnant population vaccinated	SIN	1st Tr	Nonspecified	Postpartum haemorrhage	1/105 (0.95%)
				General pregnant population vaccinated	SIN	1st Tr	Nonspecified	Pre-thrombotic status	1/105 (0.95%)
				General pregnant population vaccinated	SIN	1st Tr	Nonspecified	Prenatal Pyrexia	0/105 (0.00%)
Nguanboonmak, A (May, 2023)	Thailand (SEAR)	Comparative Cohort	99	General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Chorioamnionitis	0/99 (0.00%)
				General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Placental abruption	0/99 (0.00%)
				General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Stillbirth	0/99 (0.00%)
Li, M. (Dec, 2022)	China (WPR)	Comparative Cohort	93	General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Gestational diabetes	24/93 (25.81%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Hypertensive disorders of pregnancy	6/93 (6.45%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Hyperthyroidism	0/93 (0.00%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Hypothyroidism	3/93 (3.23%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Intrahepatic cholestasis of pregnancy	2/93 (2.15%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Oligohydramnios	1/93 (1.08%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Polyhydramnios	0/93 (0.00%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Postpartum haemorrhage	6/93 (6.45%)
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Nonspecified	Threatened abortion	14/93 (15.05%)
Shanes, E.D. (Aug, 2021)	United States (AMR)	Comparative Cohort	84	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	Non-specified	Nonspecified	Chronic histiocytic intervillositis	0/84 (0.00%)
Jarraya, A (Dec, 2023)	Tunisia (EMR)	Comparative Cohort	59	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Caesarean delivery	30/59 (50.85%)
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Postpartum haemorrhage	2/59 (3.39%)
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Preeclampsia/eclampsia	8/59 (13.56%)
Kammoun, M (Dec, 2023)	Tunisia (EMR)	Comparative Cohort	59	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Nonspecified	Caesarean delivery	17/41 (41.46%)
Boelig R. (Mar, 2022)	United States (AMR)	Comparative Cohort	49	General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Maternal vascular malperfusion	6/49 (12.24%)
Dude, C (Jan, 2023)	United States (AMR)	Comparative Cohort	34	General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Caesarean delivery	13/34 (38.24%)
Sabharwal, V. (Oct, 2023)	United States (AMR)	Comparative Cohort	25	General pregnant population vaccinated	Pfz	Global	Nonspecified	Caesarean delivery	7/25 (28.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Chorioamnionitis	3/25 (12.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Fetal growth retardation (or restriction)	3/25 (12.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Gestational diabetes	4/25 (16.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	8/25 (32.00%)
Sabharwal, V. (Jan, 2023)	United States (AMR)	Comparative Cohort	25	General pregnant population vaccinated	Mod Pfz J&J	Non-specified	Nonspecified	Caesarean delivery	7/25 (28.00%)
				General pregnant population vaccinated	Mod Pfz J&J	Non-specified	Nonspecified	Chorioamnionitis	3/25 (12.00%)
				General pregnant population vaccinated	Mod Pfz J&J	Non-specified	Nonspecified	Pathways to preterm birth	0/25 (0.00%)
Juttukonda, L. J (Sep, 2022)	United States (AMR)	Comparative Cohort	17	General pregnant population vaccinated	Mod Pfz	1st Tr	Nonspecified	Caesarean delivery	6/17 (35.29%)
				General pregnant population vaccinated	Mod Pfz	1st Tr	Nonspecified	Chorioamnionitis	3/17 (17.65%)
				General pregnant population vaccinated	Mod Pfz	1st Tr	Nonspecified	Fetal growth retardation (or restriction)	0/17 (0.00%)
Ki Hoon, A (Aug, 2022)	Korea;Rep. (WPR)	Comparative Cohort Cross-sectional	13,240	Non-specified	AZD	Global	Nonspecified	Caesarean delivery	0/1135 (0.00%)
				Non-specified	AZD	Global	Nonspecified	Complications of labor and delivery (ICD-10 O60-O75)	4/1135 (0.35%)
				Non-specified	AZD	Global	Nonspecified	encounter for delivery (ICD-10 O80-O84)	2/1135 (0.18%)
				Non-specified	AZD	Global	Nonspecified	maternal care related to the fetus and amniotic cavity and possible delivery problem(ICD-10 O30-O48)	7/1135 (0.62%)
				Non-specified	AZD	Global	Nonspecified	other maternal disorders predominantly related to pregnancy (ICD-10 O20-O29)	35/1135 (3.08%)
				Non-specified	AZD	Global	Nonspecified	other obstetric conditions, not elsewhere classified (ICD-10 O94-O99)	5/1135 (0.44%)
				Non-specified	AZD	Non-specified	Nonspecified	Miscarriage / Abortion	56/1135 (4.93%)
				Non-specified	J&J	Global	Nonspecified	Caesarean delivery	0/439 (0.00%)
				Non-specified	J&J	Global	Nonspecified	Complications of labor and delivery (ICD-10 O60-O75)	0/439 (0.00%)
				Non-specified	J&J	Global	Nonspecified	complications predominantly related to puerperium (ICD-10 O85-O92)	0/439 (0.00%)
				Non-specified	J&J	Global	Nonspecified	encounter for delivery (ICD-10 O94-O99)	1/439 (0.23%)
				Non-specified	J&J	Global	Nonspecified	Hypertensive disorders of pregnancy	0/439 (0.00%)
				Non-specified	J&J	Global	Nonspecified	maternal care related to the fetus and amniotic cavity and possible delivery problem(ICD-10 O30-O48)	2/439 (0.46%)
				Non-specified	J&J	Global	Nonspecified	other maternal disorders predominantly related to pregnancy (ICD-10 O20-O29)	3/439 (0.68%)
				Non-specified	J&J	Global	Nonspecified	other obstetric conditions, not elsewhere classified (ICD-10 O94-O99)	0/439 (0.00%)
				Non-specified	J&J	Non-specified	Nonspecified	Miscarriage / Abortion	14/439 (3.19%)
				Non-specified	Mod	Global	Nonspecified	Complications of labor and delivery (ICD-10 O60-O75)	0/1734 (0.00%)
				Non-specified	Mod	Global	Nonspecified	complications predominantly related to puerperium (ICD-10 O85-O92)	0/1734 (0.00%)
				Non-specified	Mod	Global	Nonspecified	encounter for delivery (ICD-10 O94-O99)	0/1135 (0.00%)
				Non-specified	Mod	Global	Nonspecified	maternal care related to the fetus and amniotic cavity and possible delivery problem(ICD-10 O30-O48)	0/1734 (0.00%)
				Non-specified	Mod	Global	Nonspecified	other obstetric conditions, not elsewhere classified (ICD-10 O94-O99)	0/1734 (0.00%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	Caesarean delivery	0/13440 (0.00%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	Complications of labor and delivery (ICD-10 O60-O75)	5/13440 (0.04%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	complications predominantly related to puerperium (ICD-10 O85-O92)	5/13440 (0.04%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	encounter for delivery (ICD-10 O94-O99)	3/13440 (0.02%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	Hypertensive disorders of pregnancy	1/13440 (0.01%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	maternal care related to the fetus and amniotic cavity and possible delivery problem (ICD-10 O30-O48)	13/13440 (0.10%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	other maternal disorders predominantly related to pregnancy (ICD-10 O20-O29)	52/13440 (0.39%)
				Non-specified	Mod Pfz J&J AZD	Global	Nonspecified	other obstetric conditions, not elsewhere classified (ICD-10 O94-O99)	7/13440 (0.05%)
				Non-specified	Pfz	Global	Nonspecified	Caesarean delivery	0/10132 (0.00%)
				Non-specified	Pfz	Global	Nonspecified	Complications of labor and delivery (ICD-10 O60-O75)	1/10132 (0.01%)
				Non-specified	Pfz	Global	Nonspecified	complications predominantly related to puerperium (ICD-10 O85-O92)	1/10132 (0.01%)
				Non-specified	Pfz	Global	Nonspecified	encounter for delivery (ICD-10 O94-O99)	0/10132 (0.00%)
				Non-specified	Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	0/10132 (0.00%)
				Non-specified	Pfz	Global	Nonspecified	maternal care related to the fetus and amniotic cavity and possible delivery problem (ICD-10 O30-O48)	4/10132 (0.04%)
				Non-specified	Pfz	Global	Nonspecified	other maternal disorders predominantly related to pregnancy (ICD-10 O20-O29)	14/10132 (0.14%)
				Non-specified	Pfz	Global	Nonspecified	other obstetric conditions, not elsewhere classified (ICD-10 O94-O99)	1/10132 (0.01%)
				Non-specified	Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	26/10132 (0.26%)
(-)	United Kingdom, Spain, South Africa, Brazil, United States (EUR AMR AFR)	Controlled clinical trial	173	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Nonspecified	3rd Tr	Nonspecified	Fetal growth retardation (or restriction)	1/161 (0.62%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Nonspecified	Fetal death	0/161 (0.00%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	1/161 (0.62%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Nonspecified	Preeclampsia/eclampsia	4/161 (2.48%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Nonspecified	Prelabour rupture of membranes	0/161 (0.00%)
Komine-Aizawa, S (Apr, 2022)	Japan (WPR)	Cross-sectional	5,397	General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Antenatal bleeding	46/5393 (0.85%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Antenatal bleeding	38/4834 (0.79%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Decreased fetal movement	23/5393 (0.43%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Decreased fetal movement	25/4834 (0.52%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	7/4834 (0.14%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Prelabour rupture of membranes	1/5393 (0.02%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Prelabour rupture of membranes	2/4834 (0.04%)
Yousefi, M (Dec, 2023)	Iran;Islamic Rep. ()	Cross-sectional	500	General pregnant population vaccinated	AZD SIN	2nd Tr	Mean: 2 Months	Miscarriage / Abortion	2/500 (0.40%)
Trostle, ME (Aug, 2021)	United States (AMR)	Cross-sectional	424	General pregnant population vaccinated	Mod Pfz	1st Tr	Nonspecified	Miscarriage / Abortion	8/124 (6.45%)
				General pregnant population vaccinated	Mod Pfz	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	9/317 (2.84%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr	Nonspecified	Miscarriage / Abortion	1/193 (0.52%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	30/85 (35.29%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Hypertensive disorders of pregnancy	16/85 (18.82%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Pathways to preterm birth	0/85 (0.00%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Placental abruption	1/85 (1.18%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Prelabour rupture of membranes	2/85 (2.35%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Previous placenta	1/85 (1.18%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Stillbirth	0/85 (0.00%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Fetal growth retardation (or restriction)	2/327 (0.61%)
Peretz-Machluf, R (Jan, 2024)	Israel (EUR)	Cross-sectional	223	General pregnant population vaccinated	Pfz	Non-specified	Nonspecified	Gestational diabetes	12/84 (14.29%)
				General pregnant population vaccinated	Pfz	Non-specified	Nonspecified	Placental abruption	2/84 (2.38%)
				General pregnant population vaccinated	Pfz	Non-specified	Nonspecified	Postpartum haemorrhage	8/84 (9.52%)
Maguire, S. (Sep, 2022)	Ireland (EUR)	Cross-sectional	73	Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Gestational diabetes	1/26 (3.85%)
				Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Gestational hypertension	1/26 (3.85%)
				Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Miscarriage / Abortion	0/26 (0.00%)
				Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Preeclampsia/eclampsia	2/26 (7.69%)
				Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Prelabour rupture of membranes	1/26 (3.85%)
				Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Severe COVID-19 - composite	5/26 (19.23%)
				Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Nonspecified	Stillbirth	1/26 (3.85%)
Kadali, R. A. K (Oct, 2021)	United States (AMR)	Cross-sectional	38	Health workers	Mod	Non-specified	Nonspecified	Hypertensive disorders of pregnancy	0/18 (0.00%)
				Health workers	Mod	Non-specified	Nonspecified	Miscarriage / Abortion	0/18 (0.00%)
				Health workers	Mod	Non-specified	Nonspecified	Pathways to preterm birth	0/18 (0.00%)
				Health workers	Mod Pfz	Non-specified	Nonspecified	Hypertensive disorders of pregnancy	1/38 (2.63%)
				Health workers	Mod Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	1/38 (2.63%)
				Health workers	Mod Pfz	Non-specified	Nonspecified	Pathways to preterm birth	1/38 (2.63%)
				Health workers	Pfz	Non-specified	Nonspecified	Hypertensive disorders of pregnancy	1/20 (5.00%)
				Health workers	Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	1/20 (5.00%)
				Health workers	Pfz	Non-specified	Nonspecified	Pathways to preterm birth	1/20 (5.00%)
Shimabukuro, T. T. (Jun, 2021)	United States (AMR)	Non-comparative Cohort	35,691	Health workers; live-born infants and stillbirths	Mod Pfz	Global	Nonspecified	Stillbirth	1/725 (0.14%)
Zauche, L.H. (Oct, 2021)	United States (AMR)	Non-comparative Cohort	2,456	Health workers	Pfz	1st Tr; 2nd Tr	Nonspecified	Miscarriage / Abortion	165/2456 (6.72%)
Du, T. (Oct, 2023)	China (WPR)	Non-comparative Cohort	326	General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Caesarean delivery	128/326 (39.26%)
				General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Gestational diabetes	23/326 (7.06%)
				General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Hypertensive disorders of pregnancy	19/326 (5.83%)
				General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Instrumental (Vacuum/forceps) delivery	5/326 (1.53%)
				General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Oligohydramnios	11/326 (3.37%)
				General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Polyhydramnios	8/326 (2.45%)
				General pregnant population vaccinated	SIN CRV	1st Tr	Nonspecified	Postpartum haemorrhage	12/326 (3.68%)
Ghesquiere, L. (Nov, 2023)	Canada (AMR)	Non-comparative Cohort	252	General pregnant population vaccinated	Nonspecified	1st Tr	Nonspecified	Gestational diabetes	5/88 (5.68%)
				General pregnant population vaccinated	Nonspecified	1st Tr	Nonspecified	Preeclampsia/eclampsia	8/88 (9.09%)
				General pregnant population vaccinated	Nonspecified	2nd Tr	Nonspecified	Gestational diabetes	5/140 (3.57%)
				General pregnant population vaccinated	Nonspecified	2nd Tr	Nonspecified	Preeclampsia/eclampsia	12/140 (8.57%)
				General pregnant population vaccinated	Nonspecified	3rd Tr	Nonspecified	Gestational diabetes	1/24 (4.17%)
				General pregnant population vaccinated	Nonspecified	3rd Tr	Nonspecified	Preeclampsia/eclampsia	3/24 (12.50%)
Zilver, S.J.M. (Feb, 2023)	Netherlands (EUR)	Non-comparative Cohort	178	General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Emergency caesarean	6/130 (4.62%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Stillbirth	0/130 (0.00%)
Abuzeid, O (-)	United States (AMR)	Non-comparative Cohort	159	General pregnant population vaccinated	Nonspecified	Non-specified	Nonspecified	Preeclampsia/eclampsia	9/159 (5.66%)
Arulappen, A.L. (May, 2022)	Malaysia (WPR)	Non-comparative Cohort	121	Health workers	Pfz	Global	Nonspecified	Caesarean delivery	37/121 (30.58%)
				Health workers	Pfz	Global	Nonspecified	Fetal growth retardation (or restriction)	0/121 (0.00%)
				Health workers	Pfz	Global	Nonspecified	Oligohydramnios	0/121 (0.00%)
				Health workers	Pfz	Global	Nonspecified	Polyhydramnios	0/121 (0.00%)
				Health workers	Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	1/121 (0.83%)
Proto, A. (Apr, 2024)	Italy (EUR)	Non-comparative Cohort	98	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Global	Nonspecified	Caesarean delivery	21/98 (21.43%)
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Global	Nonspecified	Instrumental (Vacuum/forceps) delivery	4/98 (4.08%)
Cassidy, A (Jul, 2023)	United States (AMR)	Non-comparative Cohort	76	General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Caesarean delivery	13/76 (17.11%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Chorioamnionitis	2/76 (2.63%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Gestational diabetes	2/76 (2.63%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	19/76 (25.00%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Stillbirth	0/76 (0.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Caesarean delivery	6/42 (14.29%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Chorioamnionitis	2/42 (4.76%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Gestational diabetes	1/42 (2.38%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	12/42 (28.57%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Stillbirth	0/42 (0.00%)
Santos, A. (Mar, 2022)	United States (AMR)	Non-comparative Cohort	48	General pregnant population vaccinated	Mod Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	6/48 (12.50%)
Arfah, N (Jul, 2021)	Malaysia (WPR)	Non-comparative Cohort	45	Health workers	Mod Pfz	Non-specified	Nonspecified	Ectopic pregnancy	1/45 (2.22%)
				Health workers	Mod Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	5/45 (11.11%)
				Health workers	Mod Pfz	Non-specified	Nonspecified	Molar pregnancy	1/45 (2.22%)
Male, V. (Mar, 2022)	United Kingdom (EUR)	Non-comparative Cohort	29	General population of whom some got accidentally pregnant during trials	AZD	Non-specified	Nonspecified	Miscarriage / Abortion	2/12 (16.67%)
				General population of whom some got accidentally pregnant during trials	Mod	Non-specified	Nonspecified	Miscarriage / Abortion	0/6 (0.00%)
				General population of whom some got accidentally pregnant during trials	Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	0/11 (0.00%)
Govindaraj, S (Jul, 2023)	United States (AMR)	Non-comparative Cohort	24	General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Caesarean delivery	8/24 (33.33%)
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Analysis unit: Total number of AEs reported

Table 3: Study characteristics and main results from studies that assessed maternal-pregnancy outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Exposed study population	Vaccine product (Dose)b	Trimester of vaccine exposurec	Time since vaccination until outcome measure	Outcome	Primary result
Favre G. (Oct, 2023)	Switzerland, France (EUR)	Case control Non-comparative Cohort	1,450	General pregnant population vaccinated	Mod Pfz	1st Tr	Mean: 8 Weeks	Miscarriage / Abortion	2/124 (1.61%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Miscarriage / Abortion	2/1326 (0.15%)
				General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Nonspecified	Stillbirth	1/1326 (0.08%)
Law, K.S (Feb, 2023)	Taiwan;China (WPR)	Comparative Cohort	450	General pregnant population vaccinated	Mod	Global	Nonspecified	Caesarean delivery	113/233 (48.50%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Gestational diabetes	35/233 (15.02%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Instrumental (Vacuum/forceps) delivery	25/233 (10.73%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Placental abruption	0/233 (0.00%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Postpartum haemorrhage	4/233 (1.72%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Preeclampsia/eclampsia	7/233 (3.00%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Stillbirth	1/233 (0.43%)
Kobayashi, C.D. (Sep, 2022)	Brazil (AMR)	Non-comparative Cohort		General pregnant population vaccinated	AZD	1st Tr	Nonspecified	Miscarriage / Abortion	9/385 (2.34%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	Antenatal bleeding	2/385 (0.52%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	Fetal death	9/385 (2.34%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	Genital bleeding (severe event)	3/385 (0.78%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	Hypertensive disorders of pregnancy	1/385 (0.26%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	Maternal death	3/385 (0.78%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	Oligohydramnios	1/385 (0.26%)
				General pregnant population vaccinated	AZD	Global	Nonspecified	preterm labor (severe event)	5/385 (1.30%)
				General pregnant population vaccinated	CRV	1st Tr	Nonspecified	Miscarriage / Abortion	3/53 (5.66%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Antenatal bleeding	3/53 (5.66%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Fetal death	3/53 (5.66%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Genital bleeding (severe event)	1/53 (1.89%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Hypertensive disorders of pregnancy	0/53 (0.00%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Maternal death	2/53 (3.77%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Oligohydramnios	1/53 (1.89%)
				General pregnant population vaccinated	CRV	Global	Nonspecified	Preterm labor (severe event)	1/53 (1.89%)
				General pregnant population vaccinated	Pfz	1st Tr	Nonspecified	Miscarriage / Abortion	12/143 (8.39%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Antenatal bleeding	2/143 (1.40%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Fetal death	14/143 (9.79%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Genital bleeding (severe event)	0/143 (0.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Hypertensive disorders of pregnancy	0/143 (0.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Maternal death	2/143 (1.40%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Oligohydramnios	0/143 (0.00%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Preterm labor (severe event)	0/143 (0.00%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	1st Tr	Nonspecified	Miscarriage / Abortion	24/582 (4.12%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Antenatal bleeding	7/582 (1.20%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Fetal death	26/582 (4.47%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Genital bleeding (severe event)	4/582 (0.69%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Hypertensive disorders of pregnancy	1/582 (0.17%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Maternal death	7/582 (1.20%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Oligohydramnios	2/582 (0.34%)
				General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Nonspecified	Preterm labor (severe event)	6/582 (1.03%)
Moro, P.L. (Aug, 2022)	United States (AMR)	Non-comparative Cohort		General pregnant population vaccinated	Mod	Global	Nonspecified	Antenatal bleeding	3/145 (2.07%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	one report each of premature rupture of membranes, rupture of membranes and delivery of a healthy neonate, ectopic pregnancy, mass in ovary (a possible ectopic pregnancy), oligohydramnios, velamentous cord insertion, and decreased levels of human chorionic gonadotropin	3/145 (2.07%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Preeclampsia/eclampsia	1/145 (0.69%)
				General pregnant population vaccinated	Mod	Global	Nonspecified	Stillbirth	2/145 (1.38%)
				General pregnant population vaccinated	Mod	Non-specified	Nonspecified	Miscarriage / Abortion	20/145 (13.79%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Antenatal bleeding	8/323 (2.48%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	one report each of premature rupture of membranes, rupture of membranes and delivery of a healthy neonate, ectopic pregnancy, mass in ovary (a possible ectopic pregnancy), oligohydramnios, velamentous cord insertion, and decreased levels of human chorionic gonadotropin	7/323 (2.17%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Preeclampsia/eclampsia	4/323 (1.24%)
				General pregnant population vaccinated	Mod Pfz	Global	Nonspecified	Stillbirth	5/323 (1.55%)
				General pregnant population vaccinated	Mod Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	56/323 (17.34%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Antenatal bleeding	5/178 (2.81%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	one report each of premature rupture of membranes, rupture of membranes and delivery of a healthy neonate, ectopic pregnancy, mass in ovary (a possible ectopic pregnancy), oligohydramnios, velamentous cord insertion, and decreased levels of human chorionic gonadotropin	4/178 (2.25%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Preeclampsia/eclampsia	3/178 (1.69%)
				General pregnant population vaccinated	Pfz	Global	Nonspecified	Stillbirth	3/178 (1.69%)
				General pregnant population vaccinated	Pfz	Non-specified	Nonspecified	Miscarriage / Abortion	36/178 (20.22%)
Moro,PL (Apr, 2022)	United States (AMR)	Non-comparative Cohort		Non-specified	J&J	Global	Nonspecified	Antenatal bleeding	6/275 (2.18%)
				Non-specified	J&J	Global	Nonspecified	Ectopic/molar pregnancy	2/275 (0.73%)
				Non-specified	J&J	Global	Nonspecified	Gestational diabetes	1/275 (0.36%)
				Non-specified	J&J	Global	Nonspecified	Maternal death	0/275 (0.00%)
				Non-specified	J&J	Global	Nonspecified	Miscarriage / Abortion	55/275 (20.00%)
				Non-specified	J&J	Global	Nonspecified	Preeclampsia/gestational hypertension	9/275 (3.27%)
				Non-specified	J&J	Global	Nonspecified	Prelabour rupture of membranes	0/275 (0.00%)
				Non-specified	J&J	Global	Nonspecified	Stillbirth	4/275 (1.45%)
				Non-specified	Mod	Global	Nonspecified	Antenatal bleeding	36/1350 (2.67%)
				Non-specified	Mod	Global	Nonspecified	Ectopic/molar pregnancy	6/1350 (0.44%)
				Non-specified	Mod	Global	Nonspecified	Gestational diabetes	4/1350 (0.30%)
				Non-specified	Mod	Global	Nonspecified	Maternal death	2/1350 (0.15%)
				Non-specified	Mod	Global	Nonspecified	Miscarriage / Abortion	341/1350 (25.26%)
				Non-specified	Mod	Global	Nonspecified	Preeclampsia/gestational hypertension	13/1350 (0.96%)
				Non-specified	Mod	Global	Nonspecified	Prelabour rupture of membranes	8/1350 (0.59%)
				Non-specified	Mod	Global	Nonspecified	Stillbirth	20/1350 (1.48%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Antenatal bleeding	101/3462 (2.92%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Ectopic/molar pregnancy	17/3462 (0.49%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Gestational diabetes	15/3462 (0.43%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Maternal death	8/3462 (0.23%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Miscarriage / Abortion	878/3462 (25.36%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Preeclampsia/gestational hypertension	43/3462 (1.24%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Prelabour rupture of membranes	25/3462 (0.72%)
				Non-specified	Mod Pfz J&J	Global	Nonspecified	Stillbirth	62/3462 (1.79%)
				Non-specified	Pfz	Global	Nonspecified	Antenatal bleeding	59/1831 (3.22%)
				Non-specified	Pfz	Global	Nonspecified	Ectopic/molar pregnancy	9/1831 (0.49%)
				Non-specified	Pfz	Global	Nonspecified	Gestational diabetes	10/1831 (0.55%)
				Non-specified	Pfz	Global	Nonspecified	Maternal death	6/1831 (0.33%)
				Non-specified	Pfz	Global	Nonspecified	Miscarriage / Abortion	479/1831 (26.16%)
				Non-specified	Pfz	Global	Nonspecified	Preeclampsia/gestational hypertension	20/1831 (1.09%)
				Non-specified	Pfz	Global	Nonspecified	Prelabour rupture of membranes	17/1831 (0.93%)
				Non-specified	Pfz	Global	Nonspecified	Stillbirth	38/1831 (2.08%)
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Maternal-Adverse events following immunizations

Non-Comparative measure

Analysis unit: Persons

Table 4: Study characteristics and main results from studies that assessed maternal-adverse events following immunizations outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Exposed study population	Vaccine product (Dose)b	Trimester of vaccine exposurec			Outcome		Primary result
(-)	United Kingdom, Spain, South Africa, Brazil, United States (EUR AMR AFR)	Controlled clinical trial	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Chills		11/161 (6.83%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Chills		19/148 (12.84%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Diarrhea		19/161 (11.80%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Diarrhea		9/148 (6.08%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fatigue		80/161 (49.69%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fatigue		74/148 (50.00%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fever		2/161 (1.24%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fever		3/148 (2.03%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Headache		55/161 (34.16%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Headache		61/148 (41.22%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Joint Pain		5/161 (3.11%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Joint Pain		20/148 (13.51%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Myalgia		20/161 (12.42%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Myalgia		40/148 (27.03%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Serious adverse events (SAEs)		20/161 (12.42%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Serious adverse events (SAEs)		21/156 (13.46%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Vomiting		8/161 (4.97%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Vomiting		14/148 (9.46%)
Artymuk, NV (Mar, 2022)	Russian Federation (EUR)	Non-comparative Cohort	Non-specified	SpV	Non-specified			Serious adverse events (SAEs)		0/9667 (0.00%)
Arulappen, A.L. (May, 2022)	Malaysia (WPR)	Non-comparative Cohort	Health workers	Pfz	Global			Chills		31/121 (25.62%)
			Health workers	Pfz	Global			Fatigue		21/121 (17.36%)
			Health workers	Pfz	Global			Fatigue		22/121 (18.18%)
			Health workers	Pfz	Global			Headache		19/121 (15.70%)
			Health workers	Pfz	Global			Headache		34/121 (28.10%)
			Health workers	Pfz	Global			Myalgia		69/121 (57.02%)
			Health workers	Pfz	Global			Myalgia		100/121 (82.64%)
			Health workers	Pfz	Global			Shivering		13/121 (10.74%)
			Health workers	Pfz	Global			Shivering		19/121 (15.70%)
Ben-Mayor Bashi, T (Nov, 2021)	Israel (EUR)	Non-comparative Cohort	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Back pain		2/58 (3.45%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Back pain		0/39 (0.00%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Chills		3/58 (5.17%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Chills		5/39 (12.82%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Dizziness		1/58 (1.72%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Dizziness		1/39 (2.56%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fatigue		9/58 (15.52%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fatigue		9/39 (23.08%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fever		0/58 (0.00%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Fever		1/39 (2.56%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Headache		5/58 (8.62%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Headache		2/39 (5.13%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Myalgia		3/58 (5.17%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Myalgia		5/39 (12.82%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Nausea		1/58 (1.72%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Nausea		0/39 (0.00%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Pain at injection site		14/58 (24.14%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Pain at injection site		8/39 (20.51%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Peripheral facial nerve paralysis		1/58 (1.72%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr			Peripheral facial nerve paralysis		0/39 (0.00%)
Bleicher, I (Sep, 2021)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	Global			Fever		3/202 (1.49%)
			General pregnant population vaccinated	Pfz	Global			Headache		22/202 (10.89%)
			General pregnant population vaccinated	Pfz	Global			Injection site reactions		134/202 (66.34%)
			General pregnant population vaccinated	Pfz	Global			Nausea		11/202 (5.45%)
			General pregnant population vaccinated	Pfz	Global			weakness		34/202 (16.83%)
Brinkley, E. (May, 2022)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	J&J	Non-specified			Anaphylaxis		0/53 (0.00%)
			General pregnant population vaccinated	J&J	Non-specified			Chills		5/53 (9.43%)
			General pregnant population vaccinated	J&J	Non-specified			Diarrhea		0/53 (0.00%)
			General pregnant population vaccinated	J&J	Non-specified			Dizziness		0/53 (0.00%)
			General pregnant population vaccinated	J&J	Non-specified			Fatigue		35/53 (66.04%)
			General pregnant population vaccinated	J&J	Non-specified			Fever		17/53 (32.08%)
			General pregnant population vaccinated	J&J	Non-specified			Headache		24/53 (45.28%)
			General pregnant population vaccinated	J&J	Non-specified			Injection site reactions		40/53 (75.47%)
			General pregnant population vaccinated	J&J	Non-specified			Joint Pain		7/53 (13.21%)
			General pregnant population vaccinated	J&J	Non-specified			Lymphadenopathy		4/53 (7.55%)
			General pregnant population vaccinated	J&J	Non-specified			Myalgia		13/53 (24.53%)
			General pregnant population vaccinated	J&J	Non-specified			Nausea		12/53 (22.64%)
			General pregnant population vaccinated	Mod	Non-specified			Anaphylaxis		0/321 (0.00%)
			General pregnant population vaccinated	Mod	Non-specified			Anaphylaxis		0/304 (0.00%)
			General pregnant population vaccinated	Mod	Non-specified			Chills		5/321 (1.56%)
			General pregnant population vaccinated	Mod	Non-specified			Chills		11/304 (3.62%)
			General pregnant population vaccinated	Mod	Non-specified			Diarrhea		5/321 (1.56%)
			General pregnant population vaccinated	Mod	Non-specified			Diarrhea		0/304 (0.00%)
			General pregnant population vaccinated	Mod	Non-specified			Dizziness		0/321 (0.00%)
			General pregnant population vaccinated	Mod	Non-specified			Dizziness		5/304 (1.64%)
			General pregnant population vaccinated	Mod	Non-specified			Fatigue		143/321 (44.55%)
			General pregnant population vaccinated	Mod	Non-specified			Fatigue		235/304 (77.30%)
			General pregnant population vaccinated	Mod	Non-specified			Fever		24/321 (7.48%)
			General pregnant population vaccinated	Mod	Non-specified			Fever		101/304 (33.22%)
			General pregnant population vaccinated	Mod	Non-specified			Headache		62/321 (19.31%)
			General pregnant population vaccinated	Mod	Non-specified			Headache		154/304 (50.66%)
			General pregnant population vaccinated	Mod	Non-specified			Injection site reactions		270/321 (84.11%)
			General pregnant population vaccinated	Mod	Non-specified			Injection site reactions		242/304 (79.61%)
			General pregnant population vaccinated	Mod	Non-specified			Joint Pain		13/321 (4.05%)
			General pregnant population vaccinated	Mod	Non-specified			Joint Pain		40/304 (13.16%)
			General pregnant population vaccinated	Mod	Non-specified			Lymphadenopathy		8/321 (2.49%)
			General pregnant population vaccinated	Mod	Non-specified			Lymphadenopathy		19/304 (6.25%)
			General pregnant population vaccinated	Mod	Non-specified			Myalgia		35/321 (10.90%)
			General pregnant population vaccinated	Mod	Non-specified			Myalgia		87/304 (28.62%)
			General pregnant population vaccinated	Mod	Non-specified			Nausea		15/321 (4.67%)
			General pregnant population vaccinated	Mod	Non-specified			Nausea		56/304 (18.42%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Anaphylaxis		5/946 (0.53%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Chills		30/946 (3.17%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Diarrhea		12/946 (1.27%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Dizziness		5/946 (0.53%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Fatigue		677/946 (71.56%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Fever		230/946 (24.31%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Headache		428/946 (45.24%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Injection site reactions		783/946 (82.77%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Joint Pain		104/946 (10.99%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Lymphadenopathy		66/946 (6.98%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Myalgia		231/946 (24.42%)
			General pregnant population vaccinated	Mod Pfz J&J	Non-specified			Nausea		134/946 (14.16%)
			General pregnant population vaccinated	Pfz	Non-specified			Anaphylaxis		5/572 (0.87%)
			General pregnant population vaccinated	Pfz	Non-specified			Anaphylaxis		0/533 (0.00%)
			General pregnant population vaccinated	Pfz	Non-specified			Chills		5/572 (0.87%)
			General pregnant population vaccinated	Pfz	Non-specified			Chills		12/533 (2.25%)
			General pregnant population vaccinated	Pfz	Non-specified			Diarrhea		5/572 (0.87%)
			General pregnant population vaccinated	Pfz	Non-specified			Diarrhea		7/533 (1.31%)
			General pregnant population vaccinated	Pfz	Non-specified			Dizziness		5/572 (0.87%)
			General pregnant population vaccinated	Pfz	Non-specified			Dizziness		5/533 (0.94%)
			General pregnant population vaccinated	Pfz	Non-specified			Fatigue		204/572 (35.66%)
			General pregnant population vaccinated	Pfz	Non-specified			Fatigue		320/533 (60.04%)
			General pregnant population vaccinated	Pfz	Non-specified			Fever		23/572 (4.02%)
			General pregnant population vaccinated	Pfz	Non-specified			Fever		87/533 (16.32%)
			General pregnant population vaccinated	Pfz	Non-specified			Headache		106/572 (18.53%)
			General pregnant population vaccinated	Pfz	Non-specified			Headache		185/533 (34.71%)
			General pregnant population vaccinated	Pfz	Non-specified			Injection site reactions		419/572 (73.25%)
			General pregnant population vaccinated	Pfz	Non-specified			Injection site reactions		371/533 (69.61%)
General pregnant population vaccinated	Pfz	Non-specified			Joint Pain		13/572 (2.27%)
General pregnant population vaccinated	Pfz	Non-specified			Joint Pain		45/533 (8.44%)
General pregnant population vaccinated	Pfz	Non-specified			Lymphadenopathy		13/572 (2.27%)
General pregnant population vaccinated	Pfz	Non-specified			Lymphadenopathy		31/533 (5.82%)
General pregnant population vaccinated	Pfz	Non-specified			Myalgia		35/572 (6.12%)
General pregnant population vaccinated	Pfz	Non-specified			Myalgia		102/533 (19.14%)
General pregnant population vaccinated	Pfz	Non-specified			Nausea		21/572 (3.67%)
General pregnant population vaccinated	Pfz	Non-specified			Nausea		48/533 (9.01%)
Cahen-Peretz, A. (Jan, 2023)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Chills		5/76 (6.58%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Fatigue		22/76 (28.95%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Fever		3/76 (3.95%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Headache		9/76 (11.84%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Joint Pain		2/76 (2.63%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Malaise		4/76 (5.26%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global			Myalgia		8/76 (10.53%)
Cassidy, A (Jul, 2023)	United States (AMR)	Non-comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global			Fatigue		24/59 (40.68%)
			General pregnant population vaccinated	Mod Pfz	Global			Fatigue		40/59 (67.80%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		2/59 (3.39%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		20/59 (33.90%)
			General pregnant population vaccinated	Mod Pfz	Global			Gastrointestinal		0/59 (0.00%)
			General pregnant population vaccinated	Mod Pfz	Global			Gastrointestinal		8/59 (13.56%)
			General pregnant population vaccinated	Mod Pfz	Global			Injection site reactions		50/60 (83.33%)
			General pregnant population vaccinated	Mod Pfz	Global			Injection site reactions		45/58 (77.59%)
			General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		7/59 (11.86%)
			General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		25/59 (42.37%)
			General pregnant population vaccinated	Pfz	Global			Fatigue		11/31 (35.48%)
			General pregnant population vaccinated	Pfz	Global			Fatigue		17/32 (53.12%)
			General pregnant population vaccinated	Pfz	Global			Fever		0/31 (0.00%)
			General pregnant population vaccinated	Pfz	Global			Fever		5/32 (15.62%)
			General pregnant population vaccinated	Pfz	Global			Gastrointestinal		0/31 (0.00%)
			General pregnant population vaccinated	Pfz	Global			Gastrointestinal		4/32 (12.50%)
			General pregnant population vaccinated	Pfz	Global			Injection site reactions		27/32 (84.38%)
			General pregnant population vaccinated	Pfz	Global			Joint Pain		2/31 (6.45%)
			General pregnant population vaccinated	Pfz	Global			Joint Pain		8/32 (25.00%)
Citu, IM (Feb, 2022)	Romania (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz J&J	3rd Tr			Arm numbness		18/227 (7.93%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Fatigue		188/227 (82.82%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Fever		23/227 (10.13%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Headache		14/227 (6.17%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Injection site reactions		175/227 (77.09%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Joint Pain		4/227 (1.76%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Lymphadenopathy		11/227 (4.85%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Myalgia		15/227 (6.61%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr			Rash		4/227 (1.76%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Arm numbness		13/173 (7.51%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Fatigue		129/173 (74.57%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Fever		19/173 (10.98%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Headache		14/173 (8.09%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Injection site reactions		131/173 (75.72%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Joint Pain		5/173 (2.89%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Lymphadenopathy		8/173 (4.62%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Myalgia		10/173 (5.78%)
			General pregnant population vaccinated; Seronegative cases	Pfz J&J	3rd Tr			Rash		3/173 (1.73%)
Dizdar, M. (Jan, 2024)	Turkey (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	1st Tr			Fatigue		1/8 (12.50%)
			General pregnant population vaccinated	Pfz	1st Tr			Fever		1/8 (12.50%)
			General pregnant population vaccinated	Pfz	1st Tr			Headache		1/8 (12.50%)
			General pregnant population vaccinated	Pfz	1st Tr			Myalgia		1/8 (12.50%)
			General pregnant population vaccinated	Pfz CRV	2nd Tr			Fatigue		7/82 (8.54%)
			General pregnant population vaccinated	Pfz CRV	2nd Tr			Fever		0/82 (0.00%)
			General pregnant population vaccinated	Pfz CRV	2nd Tr			Headache		0/82 (0.00%)
			General pregnant population vaccinated	Pfz CRV	2nd Tr			Myalgia		5/82 (6.10%)
			General pregnant population vaccinated	Pfz CRV	3rd Tr			Fatigue		6/122 (4.92%)
			General pregnant population vaccinated	Pfz CRV	3rd Tr			Fever		2/122 (1.64%)
			General pregnant population vaccinated	Pfz CRV	3rd Tr			Headache		2/122 (1.64%)
Favre, G. (May, 2022)	Switzerland (EUR)	Comparative Cohort	General pregnant population vaccinated	Mod	Global			Chills		14/623 (2.25%)
			General pregnant population vaccinated	Mod	Global			Diarrhea		8/623 (1.28%)
			General pregnant population vaccinated	Mod	Global			Diarrhea		21/623 (3.37%)
			General pregnant population vaccinated	Mod	Global			Fatigue		157/623 (25.20%)
			General pregnant population vaccinated	Mod	Global			Fatigue		376/623 (60.35%)
			General pregnant population vaccinated	Mod	Global			Fever		13/623 (2.09%)
			General pregnant population vaccinated	Mod	Global			Fever		102/623 (16.37%)
			General pregnant population vaccinated	Mod	Global			Haematoma		7/623 (1.12%)
			General pregnant population vaccinated	Mod	Global			Haematoma		8/623 (1.28%)
			General pregnant population vaccinated	Mod	Global			Headache		100/623 (16.05%)
			General pregnant population vaccinated	Mod	Global			Headache		285/623 (45.75%)
			General pregnant population vaccinated	Mod	Global			Injection site reactions		32/623 (5.14%)
			General pregnant population vaccinated	Mod	Global			Injection site reactions		37/623 (5.94%)
			General pregnant population vaccinated	Mod	Global			Itching		14/623 (2.25%)
			General pregnant population vaccinated	Mod	Global			Itching		29/623 (4.65%)
			General pregnant population vaccinated	Mod	Global			Joint Pain		24/623 (3.85%)
			General pregnant population vaccinated	Mod	Global			Joint Pain		157/623 (25.20%)
			General pregnant population vaccinated	Mod	Global			Malaise		8/623 (1.28%)
			General pregnant population vaccinated	Mod	Global			Malaise		57/623 (9.15%)
			General pregnant population vaccinated	Mod	Global			Myalgia		72/623 (11.56%)
			General pregnant population vaccinated	Mod	Global			Myalgia		231/623 (37.08%)
			General pregnant population vaccinated	Mod	Global			Nausea		8/623 (1.28%)
			General pregnant population vaccinated	Mod	Global			Nausea		55/623 (8.83%)
			General pregnant population vaccinated	Mod	Global			NR		8/623 (1.28%)
			General pregnant population vaccinated	Mod	Global			Pain		499/623 (80.10%)
			General pregnant population vaccinated	Mod	Global			Pain		507/623 (81.38%)
			General pregnant population vaccinated	Mod	Global			Redness		60/623 (9.63%)
			General pregnant population vaccinated	Mod	Global			Redness		89/623 (14.29%)
			General pregnant population vaccinated	Mod	Global			Swelling		59/623 (9.47%)
			General pregnant population vaccinated	Mod	Global			Swelling		85/623 (13.64%)
			General pregnant population vaccinated	Mod	Global			Vomiting		5/623 (0.80%)
			General pregnant population vaccinated	Mod	Global			Warmth		24/623 (3.85%)
			General pregnant population vaccinated	Mod	Global			Warmth		35/623 (5.62%)
			General pregnant population vaccinated	Pfz	Global			Chills		2/271 (0.74%)
			General pregnant population vaccinated	Pfz	Global			Chills		5/271 (1.85%)
			General pregnant population vaccinated	Pfz	Global			Diarrhea		5/271 (1.85%)
			General pregnant population vaccinated	Pfz	Global			Diarrhea		9/271 (3.32%)
			General pregnant population vaccinated	Pfz	Global			Fatigue		53/271 (19.56%)
			General pregnant population vaccinated	Pfz	Global			Fatigue		80/271 (29.52%)
			General pregnant population vaccinated	Pfz	Global			Fever		4/271 (1.48%)
			General pregnant population vaccinated	Pfz	Global			Fever		1/271 (0.37%)
			General pregnant population vaccinated	Pfz	Global			Haematoma		5/271 (1.85%)
			General pregnant population vaccinated	Pfz	Global			Headache		28/271 (10.33%)
			General pregnant population vaccinated	Pfz	Global			Headache		56/271 (20.66%)
			General pregnant population vaccinated	Pfz	Global			Injection site reactions		5/271 (1.85%)
			General pregnant population vaccinated	Pfz	Global			Injection site reactions		4/271 (1.48%)
			General pregnant population vaccinated	Pfz	Global			Itching		1/271 (0.37%)
			General pregnant population vaccinated	Pfz	Global			Itching		3/271 (1.11%)
			General pregnant population vaccinated	Pfz	Global			Joint Pain		7/271 (2.58%)
			General pregnant population vaccinated	Pfz	Global			Joint Pain		15/271 (5.54%)
			General pregnant population vaccinated	Pfz	Global			Malaise		7/271 (2.58%)
			General pregnant population vaccinated	Pfz	Global			Malaise		10/271 (3.69%)
			General pregnant population vaccinated	Pfz	Global			Myalgia		21/271 (7.75%)
			General pregnant population vaccinated	Pfz	Global			Myalgia		32/271 (11.81%)
			General pregnant population vaccinated	Pfz	Global			Nausea		6/271 (2.21%)
			General pregnant population vaccinated	Pfz	Global			NR		11/271 (4.06%)
			General pregnant population vaccinated	Pfz	Global			NR		6/271 (2.21%)
			General pregnant population vaccinated	Pfz	Global			Pain		196/271 (72.32%)
			General pregnant population vaccinated	Pfz	Global			Pain		182/271 (67.16%)
			General pregnant population vaccinated	Pfz	Global			Redness		5/271 (1.85%)
			General pregnant population vaccinated	Pfz	Global			Redness		11/271 (4.06%)
			General pregnant population vaccinated	Pfz	Global			Swelling		10/271 (3.69%)
			General pregnant population vaccinated	Pfz	Global			Swelling		14/271 (5.17%)
			General pregnant population vaccinated	Pfz	Global			Vomiting		2/271 (0.74%)
General pregnant population vaccinated	Pfz	Global			Vomiting		1/271 (0.37%)
General pregnant population vaccinated	Pfz	Global			Warmth		7/271 (2.58%)
General pregnant population vaccinated	Pfz	Global			Warmth		6/271 (2.21%)
Gandhi, A (Jun, 2022)	India (SEAR)	Comparative Cohort	General pregnant population vaccinated	AZDi	Global			Abdominal pain		4/247 (1.62%)
			General pregnant population vaccinated	AZDi	Global			Anxiety		4/247 (1.62%)
			General pregnant population vaccinated	AZDi	Global			Cold		2/247 (0.81%)
			General pregnant population vaccinated	AZDi	Global			Cough		2/247 (0.81%)
			General pregnant population vaccinated	AZDi	Global			Cough		1/247 (0.40%)
			General pregnant population vaccinated	AZDi	Global			Dizziness		1/247 (0.40%)
			General pregnant population vaccinated	AZDi	Global			Fatigue		7/247 (2.83%)
			General pregnant population vaccinated	AZDi	Global			Fatigue		6/247 (2.43%)
			General pregnant population vaccinated	AZDi	Global			Fever		139/247 (56.28%)
			General pregnant population vaccinated	AZDi	Global			Fever		131/247 (53.04%)
			General pregnant population vaccinated	AZDi	Global			Headache		6/247 (2.43%)
			General pregnant population vaccinated	AZDi	Global			Itching in palms		1/247 (0.40%)
			General pregnant population vaccinated	AZDi	Global			Myalgia		136/247 (55.06%)
			General pregnant population vaccinated	AZDi	Global			Myalgia		127/247 (51.42%)
			General pregnant population vaccinated	AZDi	Global			Pain at injection site		98/247 (39.68%)
			General pregnant population vaccinated	AZDi	Global			Pain at injection site		95/247 (38.46%)
			General pregnant population vaccinated	AZDi	Global			Serious adverse events (SAEs)		1/247 (0.40%)
			General pregnant population vaccinated	AZDi	Global			Sore throat		2/247 (0.81%)
			General pregnant population vaccinated	AZDi	Global			Sore throat		1/247 (0.40%)
			General pregnant population vaccinated	AZDi	Global			Swelling		31/247 (12.55%)
			General pregnant population vaccinated	AZDi	Global			Swelling		30/247 (12.15%)
			General pregnant population vaccinated	AZDi	Global			Vomiting		7/247 (2.83%)
Goldshtein, I (Jul, 2021)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Blurred vision		3/7530 (0.04%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Dizziness		4/7530 (0.05%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Gastrointestinal		5/7530 (0.07%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Headache		10/7530 (0.13%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Malaise		8/7530 (0.11%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Nonspecified pain		6/7530 (0.08%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Rash		4/7530 (0.05%)
Gong, Y (Oct, 2023)	China (WPR)	Non-comparative Cohort	General pregnant population vaccinated	SIN CRV	Global			Fatigue		5/111 (4.50%)
			General pregnant population vaccinated	SIN CRV	Global			Fatigue		5/112 (4.46%)
			General pregnant population vaccinated	SIN CRV	Global			Fatigue		1/51 (1.96%)
			General pregnant population vaccinated	SIN CRV	Global			Fever		2/112 (1.79%)
			General pregnant population vaccinated	SIN CRV	Global			Fever		0/51 (0.00%)
			General pregnant population vaccinated	SIN CRV	Global			Headache		1/111 (0.90%)
			General pregnant population vaccinated	SIN CRV	Global			Headache		1/112 (0.89%)
			General pregnant population vaccinated	SIN CRV	Global			Headache		0/51 (0.00%)
			General pregnant population vaccinated	SIN CRV	Global			Myalgia		2/111 (1.80%)
			General pregnant population vaccinated	SIN CRV	Global			Myalgia		1/112 (0.89%)
			General pregnant population vaccinated	SIN CRV	Global			Myalgia		0/51 (0.00%)
Hantoushzadeh, S (Jun, 2023)	Iran;Islamic Rep. ()	Non-comparative Cohort	General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Chills		1/23 (4.35%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Diarrhea		0/23 (0.00%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Fatigue		3/23 (13.04%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Fatigue		1/11 (9.09%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Fever		1/23 (4.35%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Headache		1/23 (4.35%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Injection site reactions		2/23 (8.70%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Injection site reactions		2/11 (18.18%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Myalgia		0/23 (0.00%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Myalgia		1/11 (9.09%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr			Vomiting		1/23 (4.35%)
Kachikis, A (Aug, 2021)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated; Health workers	Mod	Global			Chills		151/2970 (5.08%)
			General pregnant population vaccinated; Health workers	Mod	Global			Chills		1114/2385 (46.71%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fatigue		984/2970 (33.13%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fatigue		1869/2385 (78.36%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fever		57/2970 (1.92%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fever		598/2385 (25.07%)
			General pregnant population vaccinated; Health workers	Mod	Global			Headache		542/2970 (18.25%)
			General pregnant population vaccinated; Health workers	Mod	Global			Headache		1433/2385 (60.08%)
			General pregnant population vaccinated; Health workers	Mod	Global			Myalgia		492/2970 (16.57%)
			General pregnant population vaccinated; Health workers	Mod	Global			Myalgia		1529/2385 (64.11%)
			General pregnant population vaccinated; Health workers	Mod	Global			Pain at injection site		2787/2970 (93.84%)
			General pregnant population vaccinated; Health workers	Mod	Global			Pain at injection site		2289/2385 (95.97%)
			General pregnant population vaccinated; Health workers	Mod Pfz	Global			Medically attended adverse events (MAEs)		50/7809 (0.64%)
			General pregnant population vaccinated; Health workers	Mod Pfz	Global			Medically attended adverse events (MAEs)		156/6244 (2.50%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Chills		142/4777 (2.97%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Chills		905/3840 (23.57%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fatigue		1258/4777 (26.33%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fatigue		2315/3840 (60.29%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fever		41/4777 (0.86%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fever		408/3840 (10.62%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Headache		801/4777 (16.77%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Headache		1598/3840 (41.61%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Myalgia		527/4777 (11.03%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Myalgia		1565/3840 (40.76%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Pain at injection site		4371/4777 (91.50%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Pain at injection site		3449/3840 (89.82%)
Kadali, R. A. K (Oct, 2021)	United States (AMR)	Cross-sectional	Health workers	Mod Pfz	Non-specified			Anxiety		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Asthma exacerbation		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Atopic eczema		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Behavioral changes		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Brain fogging or reduced mental clarity		3/38 (7.89%)
			Health workers	Mod Pfz	Non-specified			Chills		18/38 (47.37%)
			Health workers	Mod Pfz	Non-specified			Cough		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Decrease in memory		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Decreased appetite		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Decreased sleep quality		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Depression		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Diarrhea		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Fatigue		22/38 (57.89%)
			Health workers	Mod Pfz	Non-specified			Fever		6/38 (15.79%)
			Health workers	Mod Pfz	Non-specified			Flushing		3/38 (7.89%)
			Health workers	Mod Pfz	Non-specified			Hay fever		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Headache		19/38 (50.00%)
			Health workers	Mod Pfz	Non-specified			Heartburn		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Heat or cold intolerance		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Increase in sleep		1/38 (2.63%)
			Health workers	Mod Pfz	Non-specified			Itching		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Joint Pain		3/38 (7.89%)
			Health workers	Mod Pfz	Non-specified			Muscle spasm		1/38 (2.63%)
			Health workers	Mod Pfz	Non-specified			Myalgia		13/38 (34.21%)
			Health workers	Mod Pfz	Non-specified			Nasal congestion		1/38 (2.63%)
			Health workers	Mod Pfz	Non-specified			Nausea		11/38 (28.95%)
			Health workers	Mod Pfz	Non-specified			Pain at injection site		37/38 (97.37%)
			Health workers	Mod Pfz	Non-specified			Palpitations or increased heart rate		2/38 (5.26%)
			Health workers	Mod Pfz	Non-specified			Psychological stress		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Rash		4/38 (10.53%)
			Health workers	Mod Pfz	Non-specified			Rash		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Seizure		0/37 (0.00%)
			Health workers	Mod Pfz	Non-specified			Shortness of breath		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Sweating		6/38 (15.79%)
			Health workers	Mod Pfz	Non-specified			Swelling		3/38 (7.89%)
			Health workers	Mod Pfz	Non-specified			Swelling of lips or oral cavity		0/38 (0.00%)
			Health workers	Mod Pfz	Non-specified			Vomiting		1/38 (2.63%)
			Health workers; known history of seizure disorder	Nonspecified	Non-specified			Seizure		1/1 (100.00%)
Kandarpa, V. (Aug, 2022)	Singapore, Malaysia (WPR)	Cross-sectional	General pregnant population vaccinated	Mod Pfz AZD CRV	Non-specified			Any reported reactions (not specified)		1620/2043 (79.30%)
			General pregnant population vaccinated	Mod Pfz AZD CRV	Non-specified			Any reported reactions (not specified)		1624/2043 (79.49%)
			General pregnant population vaccinated	Mod Pfz AZD CRV	Non-specified			Injection site reactions		1310/2043 (64.12%)
			General pregnant population vaccinated	Mod Pfz AZD CRV	Non-specified			Injection site reactions		1165/2043 (57.02%)
Komine-Aizawa, S (Apr, 2022)	Japan (WPR)	Cross-sectional	General pregnant population vaccinated	Mod Pfz	Global			Abdominal pain		54/5032 (1.07%)
			General pregnant population vaccinated	Mod Pfz	Global			Abdominal pain		114/4587 (2.49%)
			General pregnant population vaccinated	Mod Pfz	Global			Anaphylaxis		1/5032 (0.02%)
			General pregnant population vaccinated	Mod Pfz	Global			Anaphylaxis		4/4587 (0.09%)
			General pregnant population vaccinated	Mod Pfz	Global			Diarrhea		103/5032 (2.05%)
			General pregnant population vaccinated	Mod Pfz	Global			Diarrhea		137/4587 (2.99%)
			General pregnant population vaccinated	Mod Pfz	Global			Fatigue		1504/5032 (29.89%)
			General pregnant population vaccinated	Mod Pfz	Global			Fatigue		3003/4587 (65.47%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		608/5032 (12.08%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		2554/4587 (55.68%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		711/5032 (14.13%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		1756/4587 (38.28%)
			General pregnant population vaccinated	Mod Pfz	Global			Hypertensive disorders of pregnancy		5/5393 (0.09%)
			General pregnant population vaccinated	Mod Pfz	Global			Injection site reactions		1511/5032 (30.03%)
			General pregnant population vaccinated	Mod Pfz	Global			Injection site reactions		1470/4587 (32.05%)
			General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		220/5032 (4.37%)
			General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		1022/4587 (22.28%)
			General pregnant population vaccinated	Mod Pfz	Global			Other post-vaccination medical events		159/5032 (3.16%)
			General pregnant population vaccinated	Mod Pfz	Global			Other post-vaccination medical events		240/4587 (5.23%)
			General pregnant population vaccinated	Mod Pfz	Global			Pain at injection site		4873/5032 (96.84%)
			General pregnant population vaccinated	Mod Pfz	Global			Pain at injection site		4248/4587 (92.61%)
			General pregnant population vaccinated	Mod Pfz	Global			Rash		51/5032 (1.01%)
			General pregnant population vaccinated	Mod Pfz	Global			Rash		47/4587 (1.02%)
			General pregnant population vaccinated	Mod Pfz	Global			Sore throat		30/5032 (0.60%)
			General pregnant population vaccinated	Mod Pfz	Global			Sore throat		53/4587 (1.16%)
			General pregnant population vaccinated	Mod Pfz	Global			Swelling		17/5393 (0.32%)
			General pregnant population vaccinated	Mod Pfz	Global			Swelling		19/4834 (0.39%)
			General pregnant population vaccinated	Mod Pfz	Global			Vomiting		191/5032 (3.80%)
			General pregnant population vaccinated	Mod Pfz	Global			Vomiting		506/4587 (11.03%)
Kugelman, N (May, 2022)	Israel (EUR)	Non-comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			General weakness, dizziness, fever, chills, headache, vomiting, general muscle aches, fatigue, general rash.		21/102 (20.59%)
			General pregnant population vaccinated	Pfz	Non-specified			General weakness, dizziness, fever, chills, headache, vomiting, general muscle aches, fatigue, general rash.		5/102 (4.90%)
			General pregnant population vaccinated	Pfz	Non-specified			General weakness, dizziness, fever, chills, headache, vomiting, general muscle aches, fatigue, general rash.		30/102 (29.41%)
			General pregnant population vaccinated	Pfz	Non-specified			General weakness, dizziness, fever, chills, headache, vomiting, general muscle aches, fatigue, general rash.		37/102 (36.27%)
Kugelman, N. (Dec, 2021)	Israel (EUR)	Non-comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr			General weakness, dizziness, fever, headache, general muscle aches, fatigue, and general rash.		13/129 (10.08%)
			General pregnant population vaccinated	Pfz	2nd Tr			General weakness, dizziness, fever, headache, general muscle aches, fatigue, and general rash.		47/129 (36.43%)
Kugelman, N. (May, 2022)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr			General weakness, dizziness, fever, chills, headache, vomiting, general muscle aches, fatigue and general rash.		24/121 (19.83%)
			General pregnant population vaccinated	Pfz	2nd Tr			General weakness, dizziness, fever, chills, headache, vomiting, general muscle aches, fatigue and general rash.		44/121 (36.36%)
Li, M. (Dec, 2022)	China (WPR)	Comparative Cohort	General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr			Fever		0/93 (0.00%)
			General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr			Rash		0/93 (0.00%)
Lubrano, C. (Apr, 2023)	Italy (EUR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz AZD	Non-specified			Fever		3/127 (2.36%)
			General pregnant population vaccinated	Mod Pfz AZD	Non-specified			Headache		2/127 (1.57%)
			General pregnant population vaccinated	Mod Pfz AZD	Non-specified			Pain at injection site		18/127 (14.17%)
Montalti, M. (Aug, 2022)	Italy (EUR)	Cross-sectional	Health workers	Pfz	Non-specified			Diarrhea		1/31 (3.23%)
			Health workers	Pfz	Non-specified			Diarrhea		0/17 (0.00%)
			Health workers	Pfz	Non-specified			Fatigue		8/31 (25.81%)
			Health workers	Pfz	Non-specified			Fatigue		12/17 (70.59%)
			Health workers	Pfz	Non-specified			Fever		2/17 (11.76%)
			Health workers	Pfz	Non-specified			Flushing		1/17 (5.88%)
			Health workers	Pfz	Non-specified			Flushing		0/31 (0.00%)
			Health workers	Pfz	Non-specified			Headache		4/31 (12.90%)
			Health workers	Pfz	Non-specified			Headache		4/17 (23.53%)
			Health workers	Pfz	Non-specified			Injection site reactions		2/31 (6.45%)
			Health workers	Pfz	Non-specified			Injection site reactions		1/17 (5.88%)
			Health workers	Pfz	Non-specified			Lymphadenopathy		0/31 (0.00%)
			Health workers	Pfz	Non-specified			Lymphadenopathy		0/17 (0.00%)
			Health workers	Pfz	Non-specified			Myalgia		4/31 (12.90%)
			Health workers	Pfz	Non-specified			Myalgia		7/17 (41.18%)
			Health workers	Pfz	Non-specified			Nausea		20/31 (64.52%)
			Health workers	Pfz	Non-specified			Nausea		13/17 (76.47%)
			Health workers	Pfz	Non-specified			Syncope		0/31 (0.00%)
			Health workers	Pfz	Non-specified			Syncope		0/17 (0.00%)
			Health workers	Pfz	Non-specified			Tachycardia		3/31 (9.68%)
			Health workers	Pfz	Non-specified			Urticaria		0/31 (0.00%)
			Health workers	Pfz	Non-specified			Urticaria		0/17 (0.00%)
Moro, P (Apr, 2024)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global			Fatigue		11/136 (8.09%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		4/136 (2.94%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		6/136 (4.41%)
			General pregnant population vaccinated	Mod Pfz	Global			Malaise		5/136 (3.68%)
			General pregnant population vaccinated	Mod Pfz	Global			Vomiting		6/136 (4.41%)
Nakahara, A (Jun, 2022)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global			Chest pain/palpitations		2/83 (2.41%)
			General pregnant population vaccinated	Mod Pfz	Global			Cough		4/83 (4.82%)
			General pregnant population vaccinated	Mod Pfz	Global			Fatigue		0/83 (0.00%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		4/83 (4.82%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		2/83 (2.41%)
			General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		0/83 (0.00%)
			General pregnant population vaccinated	Mod Pfz	Global			Vomiting/diarrhea/abdominal pain		4/83 (4.82%)
Pandit, NB (Sep, 2023)	India (SEAR)	Comparative Cohort	General pregnant population vaccinated	AZDi	Global			Fatigue		13/511 (2.54%)
			General pregnant population vaccinated	AZDi	Global			Fever		140/511 (27.40%)
			General pregnant population vaccinated	AZDi	Global			Headache		13/511 (2.54%)
			General pregnant population vaccinated	AZDi	Global			Injection site reactions		51/511 (9.98%)
			General pregnant population vaccinated	BBV	Global			Fatigue		0/20 (0.00%)
			General pregnant population vaccinated	BBV	Global			Fever		7/20 (35.00%)
			General pregnant population vaccinated	BBV	Global			Headache		0/20 (0.00%)
			General pregnant population vaccinated	BBV	Global			Injection site reactions		4/20 (20.00%)
Popescu, D. (May, 2022)	Romania (EUR)	Comparative Cohort	General pregnant population vaccinated; COVID-19 disease during pregnancy before vaccine	Pfz	Global			Myalgia		1/91 (1.10%)
Sadarangani, M. (Feb, 2022)	Canada (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod	Global			Anaphylaxis		1/2183 (0.05%)
			General pregnant population vaccinated	Mod	Global			Chest pain/palpitations		14/2183 (0.64%)
			General pregnant population vaccinated	Mod	Global			Chest pain/palpitations		19/1216 (1.56%)
			General pregnant population vaccinated	Mod	Global			Chest tightness		7/2183 (0.32%)
			General pregnant population vaccinated	Mod	Global			Chest tightness		11/1216 (0.90%)
			General pregnant population vaccinated	Mod	Global			Cough		8/2183 (0.37%)
			General pregnant population vaccinated	Mod	Global			Cough		7/1216 (0.58%)
			General pregnant population vaccinated	Mod	Global			Difficulty in breathing		12/2183 (0.55%)
			General pregnant population vaccinated	Mod	Global			Difficulty in breathing		12/1216 (0.99%)
			General pregnant population vaccinated	Mod	Global			Dizziness		19/2183 (0.87%)
			General pregnant population vaccinated	Mod	Global			Dizziness		25/1216 (2.06%)
			General pregnant population vaccinated	Mod	Global			Eyelid swelling		1/2183 (0.05%)
			General pregnant population vaccinated	Mod	Global			Eyelid swelling		1/1216 (0.08%)
			General pregnant population vaccinated	Mod	Global			Facial swelling		1/2183 (0.05%)
			General pregnant population vaccinated	Mod	Global			Facial swelling		3/1216 (0.25%)
			General pregnant population vaccinated	Mod	Global			Fainting		4/2183 (0.18%)
			General pregnant population vaccinated	Mod	Global			Fainting		2/1216 (0.16%)
			General pregnant population vaccinated	Mod	Global			Fever		13/2183 (0.60%)
			General pregnant population vaccinated	Mod	Global			Fever		55/1216 (4.52%)
			General pregnant population vaccinated	Mod	Global			Headache		46/2183 (2.11%)
			General pregnant population vaccinated	Mod	Global			Headache		103/1216 (8.47%)
			General pregnant population vaccinated	Mod	Global			Inability to walk		5/2183 (0.23%)
			General pregnant population vaccinated	Mod	Global			Inability to walk		6/1216 (0.49%)
			General pregnant population vaccinated	Mod	Global			Injection site reactions		1884/2183 (86.30%)
			General pregnant population vaccinated	Mod	Global			Injection site reactions		1010/1216 (83.06%)
			General pregnant population vaccinated	Mod	Global			Itchy eyes		5/2183 (0.23%)
			General pregnant population vaccinated	Mod	Global			Itchy eyes		6/1216 (0.49%)
			General pregnant population vaccinated	Mod	Global			Joint Pain		15/2183 (0.69%)
			General pregnant population vaccinated	Mod	Global			Joint Pain		38/1216 (3.12%)
			General pregnant population vaccinated	Mod	Global			Loss of taste/smell		1/2183 (0.05%)
			General pregnant population vaccinated	Mod	Global			Loss of taste/smell		3/1216 (0.25%)
			General pregnant population vaccinated	Mod	Global			Loss of vision		2/2183 (0.09%)
			General pregnant population vaccinated	Mod	Global			Loss of vision		1/1216 (0.08%)
			General pregnant population vaccinated	Mod	Global			Myalgia		64/2183 (2.93%)
			General pregnant population vaccinated	Mod	Global			Myalgia		139/1216 (11.43%)
			General pregnant population vaccinated	Mod	Global			Rash		6/2183 (0.27%)
			General pregnant population vaccinated	Mod	Global			Rash		5/1216 (0.41%)
			General pregnant population vaccinated	Mod	Global			Redness of both eyes		2/2183 (0.09%)
			General pregnant population vaccinated	Mod	Global			Redness of both eyes		2/1216 (0.16%)
			General pregnant population vaccinated	Mod	Global			Seizure		1/2183 (0.05%)
			General pregnant population vaccinated	Mod	Global			Serious adverse events (SAEs)		13/2183 (0.60%)
			General pregnant population vaccinated	Mod	Global			Serious adverse events (SAEs)		11/1216 (0.90%)
			General pregnant population vaccinated	Mod	Global			Throat swelling		3/2183 (0.14%)
			General pregnant population vaccinated	Mod	Global			Throat swelling		1/1216 (0.08%)
			General pregnant population vaccinated	Mod	Global			Unilateral facial paralysis		1/2183 (0.05%)
			General pregnant population vaccinated	Mod	Global			Unilateral facial paralysis		1/1216 (0.08%)
			General pregnant population vaccinated	Mod Pfz	Global			Chest pain/palpitations		38/5597 (0.68%)
			General pregnant population vaccinated	Mod Pfz	Global			Chest pain/palpitations		26/3108 (0.84%)
			General pregnant population vaccinated	Mod Pfz	Global			Chest tightness		20/5597 (0.36%)
			General pregnant population vaccinated	Mod Pfz	Global			Chest tightness		17/3108 (0.55%)
			General pregnant population vaccinated	Mod Pfz	Global			Cough		27/5597 (0.48%)
			General pregnant population vaccinated	Mod Pfz	Global			Cough		15/3108 (0.48%)
			General pregnant population vaccinated	Mod Pfz	Global			Difficulty in breathing		29/5597 (0.52%)
			General pregnant population vaccinated	Mod Pfz	Global			Difficulty in breathing		17/3108 (0.55%)
			General pregnant population vaccinated	Mod Pfz	Global			Dizziness		49/5597 (0.88%)
			General pregnant population vaccinated	Mod Pfz	Global			Dizziness		41/3108 (1.32%)
			General pregnant population vaccinated	Mod Pfz	Global			Eyelid swelling		2/5597 (0.04%)
			General pregnant population vaccinated	Mod Pfz	Global			Facial swelling		2/5597 (0.04%)
			General pregnant population vaccinated	Mod Pfz	Global			Fainting		8/5597 (0.14%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		34/5597 (0.61%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		73/3108 (2.35%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		128/5597 (2.29%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		144/3108 (4.63%)
			General pregnant population vaccinated	Mod Pfz	Global			Inability to walk		7/5597 (0.13%)
General pregnant population vaccinated	Mod Pfz	Global			Inability to walk		8/3108 (0.26%)
General pregnant population vaccinated	Mod Pfz	Global			Injection site reactions		4515/5597 (80.67%)
General pregnant population vaccinated	Mod Pfz	Global			Injection site reactions		2440/3108 (78.51%)
General pregnant population vaccinated	Mod Pfz	Global			Itchy eyes		10/5597 (0.18%)
General pregnant population vaccinated	Mod Pfz	Global			Itchy eyes		8/3108 (0.26%)
General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		31/5597 (0.55%)
General pregnant population vaccinated	Mod Pfz	Global			Joint Pain		57/3108 (1.83%)
General pregnant population vaccinated	Mod Pfz	Global			Loss of taste/smell		10/5597 (0.18%)
General pregnant population vaccinated	Mod Pfz	Global			Loss of taste/smell		4/3108 (0.13%)
General pregnant population vaccinated	Mod Pfz	Global			Loss of vision		4/5597 (0.07%)
General pregnant population vaccinated	Mod Pfz	Global			Myalgia		168/5597 (3.00%)
General pregnant population vaccinated	Mod Pfz	Global			Myalgia		205/3108 (6.60%)
General pregnant population vaccinated	Mod Pfz	Global			Rash		14/5597 (0.25%)
General pregnant population vaccinated	Mod Pfz	Global			Rash		10/3108 (0.32%)
General pregnant population vaccinated	Mod Pfz	Global			Redness of both eyes		3/5597 (0.05%)
General pregnant population vaccinated	Mod Pfz	Global			Serious adverse events (SAEs)		31/5597 (0.55%)
General pregnant population vaccinated	Mod Pfz	Global			Serious adverse events (SAEs)		19/3108 (0.61%)
General pregnant population vaccinated	Mod Pfz	Global			Throat swelling		6/5597 (0.11%)
General pregnant population vaccinated	Mod Pfz	Global			Throat swelling		2/3108 (0.06%)
General pregnant population vaccinated	Mod Pfz	Global			Unilateral facial paralysis		3/3108 (0.10%)
General pregnant population vaccinated	Pfz	Global			Chest pain/palpitations		24/3414 (0.70%)
General pregnant population vaccinated	Pfz	Global			Chest pain/palpitations		7/1892 (0.37%)
General pregnant population vaccinated	Pfz	Global			Chest tightness		13/3414 (0.38%)
General pregnant population vaccinated	Pfz	Global			Chest tightness		6/1892 (0.32%)
General pregnant population vaccinated	Pfz	Global			Cough		19/3414 (0.56%)
General pregnant population vaccinated	Pfz	Global			Cough		8/1892 (0.42%)
General pregnant population vaccinated	Pfz	Global			Difficulty in breathing		17/3414 (0.50%)
General pregnant population vaccinated	Pfz	Global			Difficulty in breathing		5/1892 (0.26%)
General pregnant population vaccinated	Pfz	Global			Dizziness		30/3414 (0.88%)
General pregnant population vaccinated	Pfz	Global			Dizziness		16/1892 (0.85%)
General pregnant population vaccinated	Pfz	Global			Eyelid swelling		1/3414 (0.03%)
General pregnant population vaccinated	Pfz	Global			Facial swelling		1/3414 (0.03%)
General pregnant population vaccinated	Pfz	Global			Fainting		4/3414 (0.12%)
General pregnant population vaccinated	Pfz	Global			Fever		21/3414 (0.62%)
General pregnant population vaccinated	Pfz	Global			Fever		18/1892 (0.95%)
General pregnant population vaccinated	Pfz	Global			Headache		82/3414 (2.40%)
General pregnant population vaccinated	Pfz	Global			Headache		41/1892 (2.17%)
General pregnant population vaccinated	Pfz	Global			Inability to walk		2/3414 (0.06%)
General pregnant population vaccinated	Pfz	Global			Inability to walk		2/1892 (0.11%)
General pregnant population vaccinated	Pfz	Global			Injection site reactions		2631/3414 (77.07%)
General pregnant population vaccinated	Pfz	Global			Injection site reactions		1430/1892 (75.58%)
General pregnant population vaccinated	Pfz	Global			Itchy eyes		5/3414 (0.15%)
General pregnant population vaccinated	Pfz	Global			Itchy eyes		2/1892 (0.11%)
General pregnant population vaccinated	Pfz	Global			Joint Pain		16/3414 (0.47%)
General pregnant population vaccinated	Pfz	Global			Joint Pain		19/1892 (1.00%)
General pregnant population vaccinated	Pfz	Global			Loss of taste/smell		9/3414 (0.26%)
General pregnant population vaccinated	Pfz	Global			Loss of taste/smell		1/1892 (0.05%)
General pregnant population vaccinated	Pfz	Global			Loss of vision		2/3414 (0.06%)
General pregnant population vaccinated	Pfz	Global			Myalgia		104/3414 (3.05%)
General pregnant population vaccinated	Pfz	Global			Myalgia		66/1892 (3.49%)
General pregnant population vaccinated	Pfz	Global			Rash		8/3414 (0.23%)
General pregnant population vaccinated	Pfz	Global			Rash		5/1892 (0.26%)
General pregnant population vaccinated	Pfz	Global			Redness of both eyes		1/3414 (0.03%)
General pregnant population vaccinated	Pfz	Global			Serious adverse events (SAEs)		18/3414 (0.53%)
General pregnant population vaccinated	Pfz	Global			Serious adverse events (SAEs)		8/1892 (0.42%)
General pregnant population vaccinated	Pfz	Global			Throat swelling		3/3414 (0.09%)
General pregnant population vaccinated	Pfz	Global			Throat swelling		1/1892 (0.05%)
General pregnant population vaccinated	Pfz	Global			Unilateral facial paralysis		2/1892 (0.11%)
Shimabukuro, T. T. (Jun, 2021)	United States (AMR)	Non-comparative Cohort	General pregnant population vaccinated; Health workers	Mod	Global			Abdominal pain		160/7930 (2.02%)
			General pregnant population vaccinated; Health workers	Mod	Global			Abdominal pain		401/5635 (7.12%)
			General pregnant population vaccinated; Health workers	Mod	Global			Chills		442/7930 (5.57%)
			General pregnant population vaccinated; Health workers	Mod	Global			Chills		2755/5635 (48.89%)
			General pregnant population vaccinated; Health workers	Mod	Global			Diarrhea		332/5635 (5.89%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fatigue		2616/7930 (32.99%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fatigue		4541/5635 (80.59%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fever		62/7930 (0.78%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fever		664/5635 (11.78%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fever or felt feverish		453/7930 (5.71%)
			General pregnant population vaccinated; Health workers	Mod	Global			Fever or felt feverish		2594/5635 (46.03%)
			General pregnant population vaccinated; Health workers	Mod	Global			Gastrointestinal		189/7930 (2.38%)
			General pregnant population vaccinated; Health workers	Mod	Global			Headache		1581/7930 (19.94%)
			General pregnant population vaccinated; Health workers	Mod	Global			Headache		3662/5635 (64.99%)
			General pregnant population vaccinated; Health workers	Mod	Global			Injection-site itching		157/7930 (1.98%)
			General pregnant population vaccinated; Health workers	Mod	Global			Injection-site itching		193/5635 (3.43%)
			General pregnant population vaccinated; Health workers	Mod	Global			Injection-site redness		348/7930 (4.39%)
			General pregnant population vaccinated; Health workers	Mod	Global			Injection-site redness		491/5635 (8.71%)
			General pregnant population vaccinated; Health workers	Mod	Global			Injection site reactions		739/7930 (9.32%)
			General pregnant population vaccinated; Health workers	Mod	Global			Injection site reactions		1051/5635 (18.65%)
			General pregnant population vaccinated; Health workers	Mod	Global			Joint Pain		342/7930 (4.31%)
			General pregnant population vaccinated; Health workers	Mod	Global			Joint Pain		1871/5635 (33.20%)
			General pregnant population vaccinated; Health workers	Mod	Global			Myalgia		1167/7930 (14.72%)
			General pregnant population vaccinated; Health workers	Mod	Global			Myalgia		3722/5635 (66.05%)
			General pregnant population vaccinated; Health workers	Mod	Global			Nausea		638/7930 (8.05%)
			General pregnant population vaccinated; Health workers	Mod	Global			Nausea		1909/5635 (33.88%)
			General pregnant population vaccinated; Health workers	Mod	Global			pain at injection site		7360/7930 (92.81%)
			General pregnant population vaccinated; Health workers	Mod	Global			Pain at injection site		5388/5635 (95.62%)
			General pregnant population vaccinated; Health workers	Mod	Global			Rash		22/7930 (0.28%)
			General pregnant population vaccinated; Health workers	Mod	Global			Rash		18/5635 (0.32%)
			General pregnant population vaccinated; Health workers	Mod	Global			Vomiting		77/7930 (0.97%)
			General pregnant population vaccinated; Health workers	Mod	Global			Vomiting		357/5635 (6.34%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Abdominal pain		117/9052 (1.29%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Abdominal pain		316/6638 (4.76%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Chills		254/9052 (2.81%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Chills		1747/6638 (26.32%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Diarrhea		178/9052 (1.97%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Diarrhea		277/6638 (4.17%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fatigue		2406/9052 (26.58%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fatigue		4231/6638 (63.74%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fever		30/9052 (0.33%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fever		315/6638 (4.75%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fever or felt feverish		256/9052 (2.83%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Fever or felt feverish		1648/6638 (24.83%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Headache		1497/9052 (16.54%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Headache		3138/6638 (47.27%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Injection-site itching		103/9052 (1.14%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Injection-site itching		109/6638 (1.64%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Injection-site redness		160/9052 (1.77%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Injection-site redness		169/6638 (2.55%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Injection site reactions		318/9052 (3.51%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Injection site reactions		411/6638 (6.19%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Joint Pain		209/9052 (2.31%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Joint Pain		1267/6638 (19.09%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Myalgia		795/9052 (8.78%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Myalgia		2916/6638 (43.93%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Nausea		492/9052 (5.44%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Nausea		1356/6638 (20.43%)
			General pregnant population vaccinated; Health workers	Pfz	Global			pain at injection site		5886/6638 (88.67%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Pain at injection site		7602/9052 (83.98%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Rash		20/9052 (0.22%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Rash		18/6638 (0.27%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Vomiting		82/9052 (0.91%)
			General pregnant population vaccinated; Health workers	Pfz	Global			Vomiting		201/6638 (3.03%)
Sourouni, M (May, 2022)	Germany (EUR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global			Fever		6/70 (8.57%)
			General pregnant population vaccinated	Mod Pfz	Global			Pain at injection site		39/70 (55.71%)
			General pregnant population vaccinated	Mod Pfz	Global			Serious adverse events (SAEs)		0/70 (0.00%)
Süt H. (Jun, 2023)	Turkey (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz CRV	Global			Chills		4/236 (1.69%)
			General pregnant population vaccinated	Pfz CRV	Global			Diarrhea		2/236 (0.85%)
			General pregnant population vaccinated	Pfz CRV	Global			Fatigue		35/236 (14.83%)
			General pregnant population vaccinated	Pfz CRV	Global			Fever		10/236 (4.24%)
			General pregnant population vaccinated	Pfz CRV	Global			Headache		27/236 (11.44%)
			General pregnant population vaccinated	Pfz CRV	Global			Injection site reactions		109/236 (46.19%)
			General pregnant population vaccinated	Pfz CRV	Global			Joint Pain		7/236 (2.97%)
			General pregnant population vaccinated	Pfz CRV	Global			Myalgia		19/236 (8.05%)
			General pregnant population vaccinated	Pfz CRV	Global			Nausea		6/236 (2.54%)
			General pregnant population vaccinated	Pfz CRV	Global			Vomiting		5/236 (2.12%)
Theiler, R N (Aug, 2021)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz J&J	Global			Thromboembolism		0/129 (0.00%)
Toussia-Cohen, S. (Aug, 2022)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Anaphylaxis		0/84 (0.00%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Bell's palsy		0/84 (0.00%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Fatigue		32/84 (38.10%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Fever		8/84 (9.52%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Gastrointestinal		8/84 (9.52%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Headache		3/84 (3.57%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Lymphadenopathy		7/84 (8.33%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Myalgia		17/84 (20.24%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Myocarditis		0/84 (0.00%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Rash/Local pain/Local swelling		61/84 (72.62%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr			Serious adverse events (SAEs)		0/84 (0.00%)
Tripathy, G (Jul, 2023)	India (SEAR)	Comparative Cohort	General pregnant population vaccinated	AZDi	Global			Fever		5/57 (8.77%)
			General pregnant population vaccinated	AZDi	Global			Headache		2/57 (3.51%)
			General pregnant population vaccinated	AZDi	Global			Injection site reactions		0/57 (0.00%)
			General pregnant population vaccinated	AZDi	Global			Myalgia		5/57 (8.77%)
			General pregnant population vaccinated	AZDi	Global			Vomiting		1/57 (1.75%)
			General pregnant population vaccinated	BBV	Global			Fever		3/70 (4.29%)
			General pregnant population vaccinated	BBV	Global			Headache		9/70 (12.86%)
			General pregnant population vaccinated	BBV	Global			Injection site reactions		1/70 (1.43%)
			General pregnant population vaccinated	BBV	Global			Myalgia		6/70 (8.57%)
			General pregnant population vaccinated	BBV	Global			Vomiting		2/70 (2.86%)
Wiweko, B. (Sep, 2023)	Indonesia (SEAR)	Non-comparative Cohort	General pregnant population vaccinated; Health workers; Previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Nausea		70/13268 (0.53%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Chills		78/13268 (0.59%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Drowsiness		444/13268 (3.35%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Fatigue		184/13268 (1.39%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Fever		58/13268 (0.44%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Headache		200/13268 (1.51%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Injection site reactions		1676/13268 (12.63%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Joint Pain		49/13268 (0.37%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz AZD CRV	Global			Myalgia		67/13268 (0.50%)
Yousefi, M (Dec, 2023)	Iran;Islamic Rep. ()	Cross-sectional	General pregnant population vaccinated	AZD BBV SIN SpV	Global			Chills		21/500 (4.20%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Chills		18/500 (3.60%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Diarrhea		4/500 (0.80%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Diarrhea		6/500 (1.20%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Fatigue		128/500 (25.60%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Fatigue		135/500 (27.00%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Fever		54/500 (10.80%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Fever		56/500 (11.20%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Headache		80/500 (16.00%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Headache		82/500 (16.40%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Joint Pain		19/500 (3.80%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Joint Pain		18/500 (3.60%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Myalgia		75/500 (15.00%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Nausea		14/500 (2.80%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Nausea		12/500 (2.40%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Rash		6/500 (1.20%)
			General pregnant population vaccinated	AZD BBV SIN SpV	Global			Rash		3/500 (0.60%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	AZD BBV SIN SpV	Global			Fatigue		73/329 (22.19%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	AZD BBV SIN SpV	Global			Myalgia		73/329 (22.19%)
Zdanowski, W (Jan, 2022)	Poland (EUR)	Cross-sectional	Health workers; Covid 19 free group	Pfz	Non-specified			Fatigue		51/145 (35.17%)
			Health workers; Covid 19 free group	Pfz	Non-specified			Fever		2/145 (1.38%)
			Health workers; Covid 19 free group	Pfz	Non-specified			Gastrointestinal		3/145 (2.07%)
			Health workers; Covid 19 free group	Pfz	Non-specified			Headache		16/145 (11.03%)
			Health workers; Covid 19 free group	Pfz	Non-specified			Injection site reactions		138/145 (95.17%)
			Health workers; Covid 19 free group	Pfz	Non-specified			Myalgia		2/145 (1.38%)
			Health workers; Non-previous SARS-CoV-2 infection	Pfz	Non-specified			Fatigue		54/105 (51.43%)
			Health workers; Non-previous SARS-CoV-2 infection	Pfz	Non-specified			Fever		17/105 (16.19%)
			Health workers; Non-previous SARS-CoV-2 infection	Pfz	Non-specified			Gastrointestinal		9/105 (8.57%)
			Health workers; Non-previous SARS-CoV-2 infection	Pfz	Non-specified			Headache		42/105 (40.00%)
			Health workers; Non-previous SARS-CoV-2 infection	Pfz	Non-specified			Injection site reactions		93/105 (88.57%)
			Health workers; Non-previous SARS-CoV-2 infection	Pfz	Non-specified			Myalgia		29/105 (27.62%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Fatigue		7/16 (43.75%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Fatigue		10/24 (41.67%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Fever		0/16 (0.00%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Fever		0/24 (0.00%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Gastrointestinal		0/16 (0.00%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Gastrointestinal		0/24 (0.00%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Headache		1/16 (6.25%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Headache		1/24 (4.17%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Injection site reactions		14/16 (87.50%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Injection site reactions		24/24 (100.00%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Myalgia		1/16 (6.25%)
			Health workers; Previous SARS-CoV-2 infection	Pfz	Non-specified			Myalgia		1/24 (4.17%)
Zilver, S.J.M. (Feb, 2023)	Netherlands (EUR)	Non-comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global			Fatigue		58/171 (33.92%)
			General pregnant population vaccinated	Mod Pfz	Global			Fatigue		59/135 (43.70%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		5/171 (2.92%)
			General pregnant population vaccinated	Mod Pfz	Global			Fever		8/135 (5.93%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		34/171 (19.88%)
			General pregnant population vaccinated	Mod Pfz	Global			Headache		41/135 (30.37%)
			General pregnant population vaccinated	Mod Pfz	Global			Myalgia		59/171 (34.50%)
			General pregnant population vaccinated	Mod Pfz	Global			Myalgia		57/135 (42.22%)
			General pregnant population vaccinated	Mod Pfz	Global			Nausea		16/171 (9.36%)
			General pregnant population vaccinated	Mod Pfz	Global			Nausea		14/135 (10.37%)
			General pregnant population vaccinated	Mod Pfz	Global			Vomiting		2/171 (1.17%)
			General pregnant population vaccinated	Mod Pfz	Global			Vomiting		3/135 (2.22%)
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Analysis unit: Total number of AEs reported

Table 5: Study characteristics and main results from studies that assessed maternal-adverse events following immunizations outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Exposed study population	Vaccine product (Dose)b	Trimester of vaccine exposurec	Outcome		Primary result
Goruntla, N (May, 2023)	India (SEAR)	Non-comparative Cohort	General pregnant population vaccinated	AZDi	Global	Anaphylaxis		2/486 (0.41%)
			General pregnant population vaccinated	AZDi	Global	Back pain		8/486 (1.65%)
			General pregnant population vaccinated	AZDi	Global	Chills		6/486 (1.23%)
			General pregnant population vaccinated	AZDi	Global	Cold		0/486 (0.00%)
			General pregnant population vaccinated	AZDi	Global	Cough		6/486 (1.23%)
			General pregnant population vaccinated	AZDi	Global	Dizziness		14/486 (2.88%)
			General pregnant population vaccinated	AZDi	Global	Dyspnea		2/486 (0.41%)
			General pregnant population vaccinated	AZDi	Global	Fatigue		4/486 (0.82%)
			General pregnant population vaccinated	AZDi	Global	Fever		124/486 (25.51%)
			General pregnant population vaccinated	AZDi	Global	Headache		28/486 (5.76%)
			General pregnant population vaccinated	AZDi	Global	Injection site reactions		138/486 (28.40%)
			General pregnant population vaccinated	AZDi	Global	Joint Pain		8/486 (1.65%)
			General pregnant population vaccinated	AZDi	Global	Malaise		66/486 (13.58%)
			General pregnant population vaccinated	AZDi	Global	Myalgia		40/486 (8.23%)
			General pregnant population vaccinated	AZDi	Global	Rash		32/486 (6.58%)
			General pregnant population vaccinated	AZDi	Global	Thrombocytopenia		6/486 (1.23%)
			General pregnant population vaccinated	AZDi	Global	Vertigo		0/486 (0.00%)
			General pregnant population vaccinated	AZDi	Global	Vomiting		2/486 (0.41%)
			General pregnant population vaccinated	BBV	Global	Back pain		0/358 (0.00%)
			General pregnant population vaccinated	BBV	Global	Chills		4/358 (1.12%)
			General pregnant population vaccinated	BBV	Global	Cold		14/358 (3.91%)
			General pregnant population vaccinated	BBV	Global	Cough		4/358 (1.12%)
			General pregnant population vaccinated	BBV	Global	Dizziness		6/358 (1.68%)
			General pregnant population vaccinated	BBV	Global	Dyspnea		0/358 (0.00%)
			General pregnant population vaccinated	BBV	Global	Fatigue		10/358 (2.79%)
			General pregnant population vaccinated	BBV	Global	Fever		68/358 (18.99%)
			General pregnant population vaccinated	BBV	Global	Headache		30/358 (8.38%)
			General pregnant population vaccinated	BBV	Global	Injection site reactions		106/358 (29.61%)
			General pregnant population vaccinated	BBV	Global	Joint Pain		4/358 (1.12%)
			General pregnant population vaccinated	BBV	Global	Malaise		30/358 (8.38%)
			General pregnant population vaccinated	BBV	Global	Myalgia		44/358 (12.29%)
			General pregnant population vaccinated	BBV	Global	Rash		36/358 (10.06%)
			General pregnant population vaccinated	BBV	Global	Thrombocytopenia		0/358 (0.00%)
			General pregnant population vaccinated	BBV	Global	Vertigo		2/358 (0.56%)
			General pregnant population vaccinated	BBV	Global	Vomiting		0/358 (0.00%)
Harvanova, T (Jun, 2023)	Slovak Republic, Czech Republic (EUR)	Non-comparative Cohort	General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Chills		47/606 (7.76%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Fatigue		152/606 (25.08%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Fever		6/606 (0.99%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Injection site reactions		253/606 (41.75%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Joint Pain		33/606 (5.45%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Myalgia		66/606 (10.89%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Nausea		11/606 (1.82%)
			General pregnant population vaccinated	Mod Pfz AZD SpV	Non-specified	Vomiting		9/606 (1.49%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Chills		19/606 (3.14%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Fatigue		153/606 (25.25%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Fever		6/606 (0.99%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Headache		42/606 (6.93%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Injection site reactions		263/606 (43.40%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Joint Pain		17/606 (2.81%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Myalgia		34/606 (5.61%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Nausea		13/606 (2.15%)
			General pregnant population vaccinated	Mod Pfz J&J AZD SpV	Non-specified	Vomiting		8/606 (1.32%)
Kobayashi, C.D. (Sep, 2022)	Brazil (AMR)	Non-comparative Cohort	General pregnant population vaccinated	AZD	Global	Abdominal pain		3/385 (0.78%)
			General pregnant population vaccinated	AZD	Global	Deep venous thrombosis (non severe)		1/385 (0.26%)
			General pregnant population vaccinated	AZD	Global	Deep venous thrombosis (severe event)		1/385 (0.26%)
			General pregnant population vaccinated	AZD	Global	local reactions: pain; erythema, edema		3/385 (0.78%)
			General pregnant population vaccinated	AZD	Global	Other neurologic conditions: seizure/facial palsy (severe event)		0/385 (0.00%)
			General pregnant population vaccinated	AZD	Global	Stroke (severe event)		0/385 (0.00%)
			General pregnant population vaccinated	AZD	Global	Unspecific systemic symptoms (Severe event)		4/385 (1.04%)
			General pregnant population vaccinated	AZD	Global	Urinary tract infection		2/385 (0.52%)
			General pregnant population vaccinated	CRV	Global	Abdominal pain		1/53 (1.89%)
			General pregnant population vaccinated	CRV	Global	Edema		1/53 (1.89%)
			General pregnant population vaccinated	CRV	Global	Immediate hypersensitivity reactions		1/53 (1.89%)
			General pregnant population vaccinated	CRV	Global	Other neurologic conditions: seizure/facial palsy (severe event)		1/53 (1.89%)
			General pregnant population vaccinated	CRV	Global	Serious adverse events (SAEs)		18/53 (33.96%)
			General pregnant population vaccinated	CRV	Global	Stroke (severe event)		1/53 (1.89%)
			General pregnant population vaccinated	CRV	Global	Tachycardia/Hypertensive crisis		1/53 (1.89%)
			General pregnant population vaccinated	J&J	Global	Serious adverse events (SAEs)		0/1 (0.00%)
			General pregnant population vaccinated	Pfz	Global	Asthma		1/143 (0.70%)
			General pregnant population vaccinated	Pfz	Global	Deep venous thrombosis (severe event)		1/143 (0.70%)
			General pregnant population vaccinated	Pfz	Global	Edema		1/143 (0.70%)
			General pregnant population vaccinated	Pfz	Global	local reactions: pain; erythema, edema		2/143 (1.40%)
			General pregnant population vaccinated	Pfz	Global	Tachycardia/Hypertensive crisis		2/143 (1.40%)
			General pregnant population vaccinated	Pfz J&J AZD	Global	Unspecific systemic symptoms (Severe event)		4/582 (0.69%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Abdominal pain		4/582 (0.69%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Asthma		1/582 (0.17%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Deep venous thrombosis (non severe)		1/582 (0.17%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Edema		2/582 (0.34%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Immediate hypersensitivity reactions (severe events)		3/582 (0.52%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	local reactions: pain; erythema, edema		6/582 (1.03%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Rash		11/582 (1.89%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	unspecific systemic symptoms: fever, myalgia, headache		421/582 (72.34%)
			General pregnant population vaccinated	Pfz J&J AZD CRV	Global	Urinary tract infection		4/582 (0.69%)
			General pregnant population vaccinated	Pfz J&J AZD SIN	Global	Tachycardia/Hypertensive crisis		3/582 (0.52%)
Moro, P.L. (Aug, 2022)	United States (AMR)	Non-comparative Cohort	General pregnant population vaccinated	Mod	Global	Chills		10/101 (9.90%)
			General pregnant population vaccinated	Mod	Global	Dizziness		6/101 (5.94%)
			General pregnant population vaccinated	Mod	Global	Fatigue		12/101 (11.88%)
			General pregnant population vaccinated	Mod	Global	Fever		15/101 (14.85%)
			General pregnant population vaccinated	Mod	Global	Headache		16/101 (15.84%)
			General pregnant population vaccinated	Mod	Global	Injection site pain		8/101 (7.92%)
			General pregnant population vaccinated	Mod	Global	Nausea		10/101 (9.90%)
			General pregnant population vaccinated	Mod	Global	Pain		10/101 (9.90%)
			General pregnant population vaccinated	Mod	Global	Pain in extremity		6/101 (5.94%)
			General pregnant population vaccinated	Mod	Global	Vomiting		10/101 (9.90%)
			General pregnant population vaccinated	Mod Pfz	Global	Chills		26/207 (12.56%)
			General pregnant population vaccinated	Mod Pfz	Global	Dizziness		17/207 (8.21%)
			General pregnant population vaccinated	Mod Pfz	Global	Fatigue		32/207 (15.46%)
			General pregnant population vaccinated	Mod Pfz	Global	Fever		33/207 (15.94%)
			General pregnant population vaccinated	Mod Pfz	Global	Headache		42/207 (20.29%)
			General pregnant population vaccinated	Mod Pfz	Global	Injection site pain		17/207 (8.21%)
			General pregnant population vaccinated	Mod Pfz	Global	Nausea		24/207 (11.59%)
			General pregnant population vaccinated	Mod Pfz	Global	Pain		25/207 (12.08%)
			General pregnant population vaccinated	Mod Pfz	Global	Pain in extremity		19/207 (9.18%)
			General pregnant population vaccinated	Mod Pfz	Global	Vomiting		16/207 (7.73%)
			General pregnant population vaccinated	Pfz	Global	Chills		16/106 (15.09%)
			General pregnant population vaccinated	Pfz	Global	Dizziness		11/106 (10.38%)
			General pregnant population vaccinated	Pfz	Global	Fatigue		20/106 (18.87%)
			General pregnant population vaccinated	Pfz	Global	Fever		18/106 (16.98%)
			General pregnant population vaccinated	Pfz	Global	Headache		26/106 (24.53%)
			General pregnant population vaccinated	Pfz	Global	Injection site pain		9/106 (8.49%)
			General pregnant population vaccinated	Pfz	Global	Nausea		14/106 (13.21%)
			General pregnant population vaccinated	Pfz	Global	Pain		15/106 (14.15%)
			General pregnant population vaccinated	Pfz	Global	Pain in extremity		13/106 (12.26%)
			General pregnant population vaccinated	Pfz	Global	Vomiting		6/106 (5.66%)
Moro,PL (Apr, 2022)	United States (AMR)	Non-comparative Cohort	Non-specified	J&J	Global	Chills		70/1831 (3.82%)
			Non-specified	J&J	Global	Dizziness		17/1831 (0.93%)
			Non-specified	J&J	Global	Fatigue		58/1831 (3.17%)
			Non-specified	J&J	Global	Fever		77/1831 (4.21%)
			Non-specified	J&J	Global	Headache		63/1831 (3.44%)
			Non-specified	J&J	Global	Myalgia		24/1831 (1.31%)
			Non-specified	J&J	Global	Nausea		36/1831 (1.97%)
			Non-specified	J&J	Global	Pain in extremity		21/1831 (1.15%)
			Non-specified	J&J	Global	Vomiting		18/1831 (0.98%)
			Non-specified	Mod	Global	Chills		139/1831 (7.59%)
			Non-specified	Mod	Global	Dizziness		86/1831 (4.70%)
			Non-specified	Mod	Global	Fatigue		155/1831 (8.47%)
			Non-specified	Mod	Global	Fever		152/1831 (8.30%)
			Non-specified	Mod	Global	Headache		160/1831 (8.74%)
			Non-specified	Mod	Global	Injection site pain		87/1831 (4.75%)
			Non-specified	Mod	Global	Injection site reactions		88/1831 (4.81%)
			Non-specified	Mod	Global	Nausea		120/1831 (6.55%)
			Non-specified	Mod	Global	Pain in extremity		123/1831 (6.72%)
			Non-specified	Mod Pfz J&J	Global	Chills		369/3462 (10.66%)
			Non-specified	Mod Pfz J&J	Global	Dizziness		225/3462 (6.50%)
			Non-specified	Mod Pfz J&J	Global	Fatigue		422/3462 (12.19%)
			Non-specified	Mod Pfz J&J	Global	Fever		381/3462 (11.01%)
			Non-specified	Mod Pfz J&J	Global	Headache		434/3462 (12.54%)
			Non-specified	Mod Pfz J&J	Global	Injection site pain		186/3462 (5.37%)
			Non-specified	Mod Pfz J&J	Global	Nausea		299/3462 (8.64%)
			Non-specified	Mod Pfz J&J	Global	Pain in extremity		266/3462 (7.68%)
			Non-specified	Mod Pfz J&J	Global	Vomiting		165/3462 (4.77%)
			Non-specified	Pfz	Global	Chills		159/1831 (8.68%)
			Non-specified	Pfz	Global	Dizziness		122/1831 (6.66%)
			Non-specified	Pfz	Global	Fatigue		209/1831 (11.41%)
			Non-specified	Pfz	Global	Fever		152/1831 (8.30%)
			Non-specified	Pfz	Global	Headache		211/1831 (11.52%)
			Non-specified	Pfz	Global	Injection site pain		84/1831 (4.59%)
			Non-specified	Pfz	Global	Nausea		143/1831 (7.81%)
			Non-specified	Pfz	Global	Pain in extremity		122/1831 (6.66%)
			Non-specified	Pfz	Global	Vomiting		85/1831 (4.64%)
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Infant Safety Outcomes

Comparative measure

Table 6: Study characteristics and main results from studies that assessed infant safety outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Exposed study population	Vaccine product (Dose)b	Comparator	Trimester of vaccine exposurec	Outcomed	Months after birth	Primary result
Mensah, A. (Oct, 2023)	United Kingdom (EUR)	Case control	182,477	General pregnant population vaccinated	AZDi	Unvaccinated	Global	Apgar score < 7 at five minutes		OR:0.86 [0.68;1.1]
				General pregnant population vaccinated	AZDi	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.98 [0.92;1.05]
				General pregnant population vaccinated	AZDi	Unvaccinated	Global	Low birth weight		Adj OR:0.96 [0.83;1.1]
				General pregnant population vaccinated	AZDi	Unvaccinated	Global	Neonatal death		Adj OR:0.88 [0.32;2.4]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Apgar score < 7 at five minutes		Adj OR:0.92 [0.77;1.08]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.86 [0.81;0.93]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Low birth weight		Adj OR:0.8 [0.7;0.92]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Neonatal death		Adj OR:1.37 [0.76;2.48]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Apgar score < 7 at five minutes		OR:0.89 [0.8;0.98]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Apgar score < 7 at five minutes		OR:0.91 [0.8;1.02]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	1st Tr	Apgar score < 7 at five minutes		OR:1.03 [0.87;1.21]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	2nd Tr	Apgar score < 7 at five minutes		OR:1 [0.89;1.12]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	3rd Tr	Apgar score < 7 at five minutes		Adj OR:0.87 [0.77;0.97]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.89 [0.85;0.92]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.86 [0.83;0.91]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks		Adj OR:0.99 [0.94;1.03]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		Adj OR:0.91 [0.87;0.95]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		Adj OR:1.02 [0.9;1.16]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Low birth weight		Adj OR:0.86 [0.79;0.93]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Low birth weight		Adj OR:0.84 [0.76;0.93]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	1st Tr	Low birth weight		Adj OR:1.01 [0.91;1.11]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	2nd Tr	Low birth weight		Adj OR:0.84 [0.77;0.92]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	3rd Tr	Low birth weight		Adj OR:0.89 [0.82;0.97]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Neonatal death		Adj OR:1.27 [0.91;1.77]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	Global	Neonatal death		Adj OR:1.12 [0.73;1.72]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	1st Tr	Neonatal death		Adj OR:1.28 [0.79;2.08]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	2nd Tr	Neonatal death		Adj OR:0.95 [0.64;1.4]
				General pregnant population vaccinated	Mod Pfz AZDi	Unvaccinated	3rd Tr	Neonatal death		Adj OR:1.01 [0.65;1.57]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Apgar score < 7 at five minutes		OR:0.89 [0.79;1]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.86 [0.83;0.9]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Low birth weight		Adj OR:0.89 [0.82;0.97]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Neonatal death		Adj OR:1.32 [0.89;1.97]
Faherty, E (Mar, 2024)	United States (AMR)	Case control	18,863	General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Gestational age at delivery <37 weeks		RR:0.76 [0.68;0.85]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj RR:0.84 [0.75;0.94]
Alamoudi, R. A. (Jun, 2024)	Jordan, Kuwait, Oman, Egypt;Arab Rep., Saudi Arabia (EMR)	Case control	54	General pregnant population vaccinated	Nonspecified	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects		Adj OR:0.34 [0.15;0.73]
Jorgensen S. (Oct, 2023)	Canada (AMR)	Comparative Cohort	85,670	General pregnant population vaccinated	Mod	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.38 [0.2;0.72]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.87 [0.82;0.92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.59 [0.37;0.92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.42 [0.28;0.65]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.7 [0.9;5.2]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Neonatal death	0.92	Adj ARR:0.71 [0.42;1.19]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Neonatal death	0.92	Adj ARR:0.55 [0.35;0.86]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Neonatal death	0.92	Adj ARR:0.24 [0.14;0.41]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.27 [0.09;0.81]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.47 [0.33;0.65]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.95 [0.91;0.99]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.82 [0.79;0.86]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.75 [0.6;0.92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	NICU hospitalization	0.92	Adj ARR:0.87 [0.83;0.92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	NICU hospitalization	0.92	Adj ARR:0.9 [0.86;0.93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	NICU hospitalization	0.92	Adj ARR:0.79 [0.76;0.83]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.79 [0.72;0.87]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.86 [0.83;0.89]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Neonatal death	0.92	Adj ARR:0.5 [0.34;0.71]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj ARR:0.86 [0.83;0.89]
Fell, D.B. (Aug, 2022)	Canada (AMR)	Comparative Cohort	43,099	General pregnant population vaccinated	Mod	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj HR:1 [0.91;1.09]
				General pregnant population vaccinated	Mod	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj HR:1.03 [0.92;1.16]
				General pregnant population vaccinated	Mod	Unvaccinated	Non-specified	Small for gestational age		Adj HR:0.97 [0.89;1.05]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <32 weeks		Adj HR:0.8 [0.67;0.95]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <32 weeks		HR:0.79 [0.67;0.93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:1.02 [0.96;1.08]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		HR:0.97 [0.92;1.02]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks		Adj HR:0.98 [0.87;1.1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		Adj HR:0.98 [0.91;1.04]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		Adj HR:1 [0.92;1.08]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:1.04 [0.97;1.12]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj HR:1.04 [0.9;1.19]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		Adj HR:0.98 [0.93;1.03]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		HR:0.96 [0.91;1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Small for gestational age		Adj HR:1 [0.9;1.12]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Small for gestational age		Adj HR:1.02 [0.96;1.08]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Small for gestational age		Adj HR:0.93 [0.88;1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		Adj HR:1.09 [1.01;1.16]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		Adj HR:0.92 [0.87;0.97]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Small for gestational age		Adj HR:0.85 [0.75;0.96]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Spontaneous preterm		Adj HR:0.96 [0.9;1.03]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Spontaneous preterm		HR:0.88 [0.82;0.94]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj HR:0.98 [0.93;1.04]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj HR:1 [0.93;1.08]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Small for gestational age		Adj HR:0.98 [0.93;1.03]
Fell, DB (Jul, 2023)	Canada (AMR)	Comparative Cohort	32,689	General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Apgar score < 7 at five minutes		Adj HR:0.96 [0.82;1.14]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Gestational age at delivery <32 weeks		Adj HR:0.83 [0.68;1.03]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Gestational age at delivery <37 weeks		Adj HR:0.91 [0.84;0.99]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	NICU hospitalization		Adj HR:0.96 [0.9;1.03]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Small for gestational age		Adj HR:0.86 [0.79;0.93]
Magnus, M.C. (Mar, 2022)	Sweden, Norway (EUR)	Comparative Cohort	28,506	General pregnant population vaccinated	Mod	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:0.89 [0.67;1.18]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	OR:0.97 [0.75;1.26]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:1.06 [0.93;1.2]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Gestational age at delivery <37 weeks		HR:1.04 [0.92;1.17]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	NICU hospitalization		Adj OR:0.87 [0.77;0.99]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	NICU hospitalization		OR:0.93 [0.83;1.05]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Small for gestational age		Adj OR:1.01 [0.89;1.15]
				General pregnant population vaccinated	Mod	Unvaccinated	Global	Small for gestational age		OR:0.94 [0.83;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:0.94 [0.84;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	Apgar score < 7 at five minutes	0.00	Adj OR:1.07 [0.83;1.39]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	Apgar score < 7 at five minutes	0.00	Adj OR:0.84 [0.71;0.99]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:0.98 [0.79;1.2]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:0.93 [0.82;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	OR:0.95 [0.86;1.05]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	Apgar score < 7 at five minutes	0.00	OR:1.07 [0.89;1.3]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	Apgar score < 7 at five minutes	0.00	OR:0.8 [0.59;1.09]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	OR:1.02 [0.184;1.23]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	OR:0.92 [0.82;1.04]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <32 weeks		Adj HR:0.91 [0.63;1.31]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <32 weeks		HR:0.91 [0.63;1.13]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.98 [0.91;1.05]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		HR:0.98 [0.92;1.05]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		Adj HR:0.97 [0.89;1.07]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		Adj HR:0.97 [0.87;1.07]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.98 [0.86;1.11]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.96 [0.84;1.1]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		HR:1.01 [0.93;1.1]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		HR:0.94 [0.85;1.04]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		HR:0.96 [0.87;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		HR:1 [0.93;1.08]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Iatrogenic preterm birth		Adj HR:1.02 [0.91;1.14]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Iatrogenic preterm birth		HR:1.05 [0.94;1.17]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	NICU hospitalization		Adj OR:0.95 [0.85;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	NICU hospitalization		Adj OR:0.94 [0.7;1.28]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	NICU hospitalization		Adj OR:0.89 [0.83;0.96]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	NICU hospitalization		Adj OR:1.03 [0.91;1.18]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	NICU hospitalization		Adj OR:0.93 [0.82;1.05]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	NICU hospitalization		OR:0.98 [0.82;1.16]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	NICU hospitalization		OR:1.04 [0.8;1.35]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	NICU hospitalization		OR:0.89 [0.84;0.95]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	NICU hospitalization		OR:1.1 [1.02;1.2]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	NICU hospitalization		OR:0.93 [0.72;1.19]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age		Adj OR:0.98 [0.93;1.04]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	Small for gestational age		Adj OR:1.04 [0.94;1.14]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	Small for gestational age		Adj OR:0.94 [0.87;1.01]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age		Adj OR:1.01 [0.92;1.12]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age		Adj OR:0.97 [0.92;1.03]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age		OR:0.92 [0.83;1.03]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	2nd Tr	Small for gestational age		OR:0.97 [0.85;1.12]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	3rd Tr	Small for gestational age		OR:0.87 [0.78;0.98]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age		OR:0.94 [0.85;1.02]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age		OR:0.92 [0.82;1.03]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Spontaneous preterm		Adj HR:0.96 [0.88;1.05]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Spontaneous preterm		HR:0.95 [0.88;1.04]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:0.93 [0.81;1.07]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	OR:0.96 [0.84;1.1]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.96 [0.898;1.04]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		HR:0.97 [0.91;1.05]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	NICU hospitalization		Adj OR:1.03 [0.96;1.1]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	NICU hospitalization		OR:1.09 [1.03;1.16]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age		Adj OR:0.96 [0.9;1.03]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age		OR:0.87 [0.82;0.93]
Fell, DB (Mar, 2022)	Canada (AMR)	Comparative Cohort	22,660	General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes		Adj RR:0.88 [0.77;1.01]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	NICU hospitalization		Adj RR:0.92 [0.87;0.97]
				General pregnant population vaccinated	Mod Pfz	Vaccine after pregnancy	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes		Adj RR:0.84 [0.73;0.97]
				General pregnant population vaccinated	Mod Pfz	Vaccine after pregnancy	2nd Tr; 3rd Tr	NICU hospitalization		Adj RR:0.85 [0.8;0.9]
Hatami, D (Mar, 2024)	Iran;Islamic Rep. ()	Comparative Cohort	17,485	General pregnant population vaccinated	SIN	Unvaccinated	Global	Any congenital malformation(s) or birth defects		OR:0.82 [0.51;1.3]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Any congenital malformation(s) or birth defects		OR:1.23 [0.9;1.68]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Any congenital malformation(s) or birth defects		Adj OR:0.76 [0.46;1.24]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Any congenital malformation(s) or birth defects		Adj RR:1.16 [0.84;1.61]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects		OR:1.46 [0.65;3.29]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Any congenital malformation(s) or birth defects		OR:1.28 [0.94;1.75]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Any congenital malformation(s) or birth defects		OR:0.63 [0.36;1.09]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects		Adj OR:1.5 [0.66;3.38]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Any congenital malformation(s) or birth defects		Adj OR:1.21 [0.87;1.68]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Any congenital malformation(s) or birth defects		Adj OR:0.55 [0.3;1.01]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Apgar score < 7 at five minutes		OR:0.84 [0.66;1.08]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Apgar score < 7 at five minutes		OR:0.65 [0.52;0.81]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Apgar score < 7 at five minutes		Adj OR:0.87 [0.62;1.24]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Apgar score < 7 at five minutes		Adj OR:1.06 [0.8;1.4]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Apgar score < 7 at five minutes		OR:1.04 [0.62;1.74]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Apgar score < 7 at five minutes		OR:0.89 [0.73;1.08]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Apgar score < 7 at five minutes		OR:0.38 [0.26;0.55]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Apgar score < 7 at five minutes		Adj OR:1.04 [0.5;2.16]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Apgar score < 7 at five minutes		Adj OR:1.04 [0.8;1.36]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Apgar score < 7 at five minutes		Adj OR:0.8 [0.51;1.27]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <28 weeks		OR:0.77 [0.6;0.98]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <28 weeks		OR:0.43 [0.33;0.56]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <28 weeks		Adj OR:0.73 [0.56;0.95]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <28 weeks		Adj OR:0.43 [0.33;0.56]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Gestational age at delivery <28 weeks		OR:0.8 [0.46;1.39]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Gestational age at delivery <28 weeks		OR:0.76 [0.62;0.93]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Gestational age at delivery <28 weeks		OR:0.18 [0.11;0.3]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Gestational age at delivery <28 weeks		Adj OR:0.77 [0.43;1.38]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Gestational age at delivery <28 weeks		Adj OR:0.72 [0.58;0.9]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Gestational age at delivery <28 weeks		Adj OR:0.2 [0.12;0.33]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <37 weeks		OR:1.07 [0.98;1.16]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <37 weeks		OR:0.91 [0.84;0.98]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:1 [0.91;1.1]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.85 [0.79;0.92]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks		OR:1.41 [1.17;1.68]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		OR:1.07 [1;1.15]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		OR:0.72 [0.65;0.8]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks		Adj OR:1.27 [1.04;1.55]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		Adj OR:1 [0.93;1.08]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		Adj OR:0.68 [0.61;0.77]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Low birth weight		OR:0.98 [0.88;1.08]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Low birth weight		OR:0.89 [0.81;0.97]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Low birth weight		Adj OR:0.99 [0.86;1.14]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Low birth weight		Adj OR:1.08 [0.97;1.21]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Low birth weight		OR:1.33 [1.08;1.63]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Low birth weight		OR:0.99 [0.91;1.08]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Low birth weight		OR:0.72 [0.64;0.82]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Low birth weight		Adj OR:1.27 [0.96;1.67]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Low birth weight		Adj OR:0.99 [0.88;1.11]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Low birth weight		Adj OR:1.11 [0.96;1.28]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Neonatal death		OR:0.56 [0.23;1.38]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Neonatal death		OR:0.71 [0.37;1.35]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Neonatal death		Adj OR:0.62 [0.22;1.74]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Neonatal death		Adj OR:1.4 [0.76;2.94]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Neonatal death		OR:1.27 [0.31;5.1]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Neonatal death		OR:0.82 [0.44;1.51]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Neonatal death		OR:0.25 [0.06;1.02]
				General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	Neonatal death		Adj OR:1.34 [0.29;6.03]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	Neonatal death		Adj OR:1.25 [0.66;2.39]
				General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	Neonatal death		Adj OR:0.36 [0.04;2.65]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	NICU hospitalization		OR:1.06 [0.98;1.15]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	NICU hospitalization		OR:0.95 [0.88;1.01]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	NICU hospitalization		Adj OR:1.02 [0.93;1.11]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	NICU hospitalization		Adj OR:0.99 [0.92;1.07]
General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	NICU hospitalization		OR:1.24 [1.04;1.48]
General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	NICU hospitalization		OR:1.01 [0.95;1.09]
General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	NICU hospitalization		OR:0.9 [0.82;0.98]
General pregnant population vaccinated	SIN	Unvaccinated	1st Tr	NICU hospitalization		Adj OR:1.15 [0.94;1.4]
General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr	NICU hospitalization		Adj OR:1.01 [0.94;1.09]
General pregnant population vaccinated	SIN	Unvaccinated	3rd Tr	NICU hospitalization		Adj OR:0.95 [0.86;1.05]
Hui, L (May, 2023)	Australia (WPR)	Comparative Cohort	17,365	General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Special care nursery		Adj OR:0.92 [0.8;1.06]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Any congenital malformation(s) or birth defects		Adj OR:0.72 [0.56;0.94]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Apgar score < 7 at five minutes		Adj OR:0.72 [0.51;1.01]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.6 [0.51;0.71]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	NICU hospitalization		Adj OR:0.7 [0.53;0.91]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age		Adj OR:1.07 [0.79;1.44]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Spontaneous preterm		Adj OR:0.73 [0.56;0.96]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Any congenital malformation(s) or birth defects		OR:1 [0.3;3.4]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Gestational age at delivery <37 weeks		OR:0.3 [0.1;0.8]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Iatrogenic preterm birth		OR:0.5 [0.2;1.3]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Spontaneous preterm		OR:0.1 [0;1]
				General pregnant population vaccinated; Vaccinated <20 weeks	Nonspecified	Unvaccinated	1st Tr; 2nd Tr	Special care nursery		Adj OR:0.9 [0.77;1.05]
				General pregnant population vaccinated; Vaccinated <20 weeks	Pfz	Unvaccinated	1st Tr; 2nd Tr	Any congenital malformation(s) or birth defects		Adj OR:0.8 [0.57;1.13]
				General pregnant population vaccinated; Vaccinated <20 weeks	Pfz	Unvaccinated	1st Tr; 2nd Tr	Gestational age at delivery <37 weeks		Adj OR:0.58 [0.48;0.71]
				General pregnant population vaccinated; Vaccinated <20 weeks	Pfz	Unvaccinated	1st Tr; 2nd Tr	Iatrogenic preterm birth		Adj OR:0.48 [0.36;0.63]
				General pregnant population vaccinated; Vaccinated <20 weeks	Pfz	Unvaccinated	1st Tr; 2nd Tr	NICU hospitalization		Adj OR:0.81 [0.61;1.09]
				General pregnant population vaccinated; Vaccinated <20 weeks	Pfz	Unvaccinated	1st Tr; 2nd Tr	Spontaneous preterm		Adj OR:0.73 [0.73;0.99]
Goldshtein, I (Feb, 2022)	Israel (EUR)	Comparative Cohort	16,738	General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects	2.07	Adj RR:0.69 [0.44;1.04]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <32 weeks		Adj RR:0.45 [0.29;0.7]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Gestational age at delivery <32 weeks		Adj RR:0.24 [0.07;0.61]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj RR:0.95 [0.83;1.1]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks		Adj RR:0.87 [0.67;1.12]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks		Adj RR:0.87 [0.67;1.12]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery 32-36 weeks		Adj RR:1.03 [0.89;1.2]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Gestational age at delivery 32-36 weeks		Adj RR:1 [0.76;1.3]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Heart malformations	2.07	Adj RR:0.75 [0.43;1.26]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Infant death	4.40	Adj RR:0.84 [0.43;1.72]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Infant death	2.07	Adj RR:0.69 [0.14;2.41]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Low birth weight		Adj RR:0.89 [0.78;1.01]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Low birth weight		Adj RR:0.95 [0.74;1.22]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Major heart malformations	2.07	Adj RR:0.46 [0.24;0.82]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	NICU hospitalization	0.92	Adj RR:0.99 [0.88;1.12]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	NICU hospitalization	0.92	Adj RR:0.86 [0.67;1.09]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Phototherapy	4.40	Adj RR:1.24 [0.95;1.63]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Phototherapy	2.07	Adj RR:1.71 [1.06;2.73]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Postneonatal (>28 d after birth) All cause hospitalizations	2.07	RR:0.78 [0.54;1.09]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Postneonatal hospitalization	4.40	Adj RR:0.95 [0.84;1.07]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age		Adj RR:0.97 [0.87;1.08]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Small for gestational age		Adj RR:1.14 [0.92;1.4]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Very low birth weight		Adj RR:0.41 [0.26;0.65]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Very low birth weight		Adj RR:0.23 [0.07;0.61]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Gestational age at delivery <32 weeks		Adj RR:0.58 [0.35;0.98]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Gestational age at delivery 32-36 weeks		Adj RR:0.99 [0.84;1.16]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Infant death	4.47	Adj RR:0.84 [0.43;1.72]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Low birth weight		Adj RR:0.88 [0.75;1.02]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	NICU hospitalization	0.92	Adj RR:1.02 [0.89;1.16]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	NICU hospitalization	4.47	Adj RR:1.01 [0.88;1.16]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Phototherapy	4.47	Adj RR:1.46 [1.06;2.06]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Small for gestational age		Adj RR:0.95 [0.84;1.07]
				General pregnant population vaccinated; No COVID-19 infection pre-birth	Pfz	Unvaccinated; No COVID-19 infection pre-birth	Global	Very low birth weight		Adj RR:0.53 [0.32;0.92]
Lindsay L. (Aug, 2023)	United Kingdom (EUR)	Comparative Cohort	11,379	General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:1.13 [0.93;1.37]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:1.08 [0.9;1.3]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <32 weeks	0.00	Adj OR:0.89 [0.64;1.23]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <32 weeks	0.00	Adj OR:0.88 [0.67;1.16]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	Adj OR:0.96 [0.86;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	Adj OR:0.93 [0.84;1.03]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Neonatal death	0.92	Adj OR:0.51 [0.26;1.01]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Neonatal death	0.92	Adj OR:0.56 [0.29;1.06]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age	0.00	Adj OR:1.02 [0.9;1.16]
				General pregnant population vaccinated	Mod Pfz AZD	Unvaccinated	Global	Small for gestational age	0.00	Adj OR:0.89 [0.79;0.99]
Lipkind, HS (Jan, 2022)	United States (AMR)	Comparative Cohort	10,064	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.78 [0.66;0.93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.97 [0.86;1.1]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		Adj HR:0.92 [0.8;1.07]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		Adj HR:0.98 [0.89;1.08]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj HR:0.91 [0.82;1.01]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		Adj HR:0.82 [0.72;0.94]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Small for gestational age		Adj HR:0.95 [0.87;1.03]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	2nd Tr	Small for gestational age		Adj HR:1 [0.86;1.17]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	3rd Tr	Small for gestational age		Adj HR:0.93 [0.85;1.02]
				General pregnant population vaccinated	Pfz J&J AZD	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		Adj HR:1.05 [0.9;1.23]
Tavares Veras Florentino, P (Sep, 2023)	Brazil (AMR)	Comparative Cohort	6,343	General pregnant population vaccinated	CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.91 [0.77;1.08]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.68 [0.4;1.3]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.88 [0.71;1.11]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:1.07 [0.82;1.51]
				General pregnant population vaccinated	CRV	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks	0.00	HR:0.79 [0.61;1.06]
				General pregnant population vaccinated	CRV	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks	0.00	HR:1.11 [0.84;1.54]
				General pregnant population vaccinated	CRV	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks	0.00	HR:0.85 [0.58;1.24]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Low birth weight	0.00	HR:0.84 [0.68;1.02]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Low birth weight	0.00	HR:0.4 [0.19;0.91]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Low birth weight	0.00	HR:0.9 [0.7;1.19]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Low birth weight	0.00	HR:0.88 [0.61;1.22]
				General pregnant population vaccinated	CRV	Unvaccinated	1st Tr	Low birth weight	0.00	HR:0.82 [0.62;1.15]
				General pregnant population vaccinated	CRV	Unvaccinated	2nd Tr	Low birth weight	0.00	HR:0.86 [0.6;1.26]
				General pregnant population vaccinated	CRV	Unvaccinated	3rd Tr	Low birth weight	0.00	HR:0.83 [0.6;1.32]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.05 [0.84;1.28]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:0.81 [0.44;1.56]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.06 [0.83;1.47]
				General pregnant population vaccinated	CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.11 [0.85;1.54]
				General pregnant population vaccinated	CRV	Unvaccinated	1st Tr	Small for gestational age	0.00	HR:1.03 [0.72;1.46]
				General pregnant population vaccinated	CRV	Unvaccinated	2nd Tr	Small for gestational age	0.00	HR:0.99 [0.69;1.49]
				General pregnant population vaccinated	CRV	Unvaccinated	3rd Tr	Small for gestational age	0.00	HR:1.11 [0.85;1.53]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:1 [0.88;1.11]
				General pregnant population vaccinated	Pfz	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks	0.00	HR:0.75 [0.59;0.99]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:1.04 [87;1.28]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.98 [0.86;1.14]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.98 [0.66;1.45]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks	0.00	HR:1.1 [0.8;1.59]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks	0.00	HR:1.04 [0.93;1.19]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Low birth weight	0.00	HR:1.02 [0.87;1.18]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Low birth weight	0.00	HR:1.01 [0.83;1.32]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Low birth weight	0.00	HR:1.02 [0.88;1.23]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Low birth weight	0.00	HR:0.98 [0.64;1.49]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Low birth weight	0.00	HR:1.06 [0.79;1.63]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr	Low birth weight	0.00	HR:1.03 [0.88;1.21]
				General pregnant population vaccinated	Pfz	Unvaccinated	3rd Tr	Low birth weight	0.00	HR:0.91 [0.72;1.29]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age	0.00	HR:1.1 [0.95;1.27]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age	0.00	HR:1.12 [0.86;1.5]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age	0.00	HR:1.06 [0.89;1.31]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Small for gestational age	0.00	HR:1.22 [0.88;1.79]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr	Small for gestational age	0.00	HR:0.85 [0.58;1.39]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr	Small for gestational age	0.00	HR:1.13 [0.93;1.35]
				General pregnant population vaccinated	Pfz	Unvaccinated	3rd Tr	Small for gestational age	0.00	HR:1.16 [0.91;1.45]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	HR:0.81 [0.55;1.22]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	1st Tr	Gestational age at delivery <37 weeks	0.00	HR:0.96 [0.76;1.21]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks	0.00	HR:1.05 [0.93;1.19]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks	0.00	HR:0.78 [0.63;0.98]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.98 [0.88;1.1]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:1.01 [0.84;1.25]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:0.96 [0.86;1.09]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	HR:1.04 [0.84;1.32]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Low birth weight		HR:1 [0.88;1.14]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Low birth weight	0.00	HR:0.97 [0.79;1.24]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Low birth weight	0.00	HR:1.02 [0.87;1.18]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Low birth weight	0.00	HR:0.94 [0.72;1.28]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	1st Tr	Low birth weight	0.00	HR:0.97 [0.73;1.29]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	2nd Tr	Low birth weight	0.00	HR:0.97 [0.85;1.13]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	3rd Tr	Low birth weight	0.00	HR:1.09 [0.93;1.4]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Neonatal death		HR:0.88 [0.56;1.48]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.09 [0.96;1.27]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.09 [0.85;1.4]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.06 [0.9;1.25]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Small for gestational age	0.00	HR:1.16 [0.93;1.45]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	1st Tr	Small for gestational age	0.00	HR:0.93 [0.69;1.26]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	2nd Tr	Small for gestational age	0.00	HR:1.11 [0.94;1.32]
General pregnant population vaccinated	Pfz CRV	Unvaccinated	3rd Tr	Small for gestational age	0.00	HR:1.14 [0.94;1.39]
Darwin, K (Aug, 2023)	United States (AMR)	Comparative Cohort	5,749	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Gestational age at delivery <28 weeks		Adj OR:0.69 [0.65;0.74]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Gestational age at delivery <28 weeks		OR:0.69 [0.65;0.73]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj OR:0.81 [0.79;0.82]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		OR:0.83 [0.81;0.85]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Low birth weight	0.00	OR:0.87 [0.73;1.04]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Non-specified	Low birth weight	0.00	Adj OR:0.87 [0.71;1.04]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <28 weeks		Adj OR:0.57 [0.55;0.6]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <28 weeks		Adj OR:0.52 [0.49;0.54]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <28 weeks		OR:0.57 [0.55;0.6]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <28 weeks		OR:0.52 [0.49;0.55]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj OR:0.74 [0.73;0.75]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		Adj RR:0.71 [0.7;0.72]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		OR:0.75 [0.75;0.76]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		RR:0.72 [0.71;0.73]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Low birth weight	0.00	OR:0.79 [0.69;0.89]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Low birth weight	0.00	Adj OR:0.8 [0.7;0.91]
Peretz-Machluf, R (Apr, 2022)	Israel (EUR)	Comparative Cohort	3,240	General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks		Adj OR:0.94 [0.62;1.44]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	NICU hospitalization		Adj OR:1.06 [0.54;2.1]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age		Adj OR:1.01 [0.66;1.55]
Dick, A (Apr, 2022)	Israel (EUR)	Comparative Cohort	3,139	General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	0.00	Adj OR:0.27 [0.04;1.98]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks		Adj OR:0.67 [0.37;1.23]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age		Adj OR:1.1 [0.68;1.82]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	0.00	Adj OR:0.24 [0.033;1.77]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks		Adj OR:0.61 [0.33;1.11]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Small for gestational age		Adj OR:1.2 [0.72;2]
Villar, J. (Jan, 2023)	NigeriaMexico, Japan, Italy, Israel, Indonesia, France, Egypt;Arab Rep., Brazil, Argentina (EUR WPR AMR AFR SEAR)	Comparative Cohort	2,886	General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Any congenital malformation(s) or birth defects		RR:0.85 [0.59;1.21]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		RR:0.81 [0.68;0.96]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Respiratory distress in the newborn		RR:0.79 [0.62;1.01]
McClymont E. (Oct, 2023)	Canada (AMR)	Comparative Cohort	2,868	General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Gestational age at delivery <37 weeks		OR:0.85 [0.65;1.11]
				General pregnant population vaccinated	Mod Pfz J&J AZD	Unvaccinated	Global	Neonatal death		OR:NA [0.24;NA]
Ruderman, R (Apr, 2022)	United States (AMR)	Comparative Cohort	2,622	General pregnant population vaccinated; Vaccinated pregnant individuals within the teratogenic window	Nonspecified	Versus other COVID-19 vaccine exposure; Vaccinated pregnant individuals outside teratogenic window	1st Tr; 2nd Tr	Any congenital malformation(s) or birth defects		OR:1.01 [0.69;1.48]
				General pregnant population vaccinated; Vaccinated pregnant individuals within the teratogenic window	Nonspecified	Versus other COVID-19 vaccine exposure; Vaccinated pregnant individuals outside teratogenic window (30 days before conception to 14 weeks gestation)	1st Tr; 2nd Tr	Any congenital malformation(s) or birth defects		Adj OR:1.05 [0.72;1.54]
Dick, A (Feb, 2022)	Israel (EUR)	Comparative Cohort	2,305	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Apgar score < 7 at five minutes	0.00	Adj OR:0.92 [0.6;1.43]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Gestational age at delivery <37 weeks		Adj OR:0.93 [0.76;1.21]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Gestational age at delivery <37 weeks		Adj OR:1.49 [1.11;2.01]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Gestational age at delivery <37 weeks		Adj OR:0.49 [0.34;0.71]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Small for gestational age		Adj OR:0.81 [0.65;1.05]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Small for gestational age		Adj OR:0.73 [0.52;1.03]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Small for gestational age		Adj OR:0.85 [0.64;1.13]
Rottenstreich, M. (Sep, 2022)	Israel (EUR)	Comparative Cohort	1,720	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Unvaccinated; Non-previous SARS-CoV-2 infection	Non-specified	risk of composite adverse neonatal outcome		Adj OR:0.6 [0.42;0.86]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	Non-specified	Risk of composite adverse neonatal outcome		Adj OR:0.7 [0.53;1.035]
Favre, G (Jun, 2023)	Switzerland, France (EUR)	Comparative Cohort	1,450	General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	1st Tr	Any congenital malformation(s) or birth defects	0.00	RR:0.89 [0.12;6.8]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	1st Tr	Any congenital malformation(s) or birth defects	0.00	Adj RR:1.01 [0.13;7.73]
Santos, J (Apr, 2024)	United States (AMR)	Comparative Cohort	1,098	General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects		Adj OR:0.92 [0.69;1.24]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	2nd Tr; 3rd Tr	Any congenital malformation(s) or birth defects		Adj OR:0.93 [0.77;1.13]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	1st Tr	Small for gestational age		Adj OR:0.89 [0.54;1.44]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age		Adj OR:1.14 [0.86;1.52]
Vuong, L.N. (May, 2022)	Vietnam (WPR)	Comparative Cohort	954	General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Gestational age at delivery <32 weeks		RR:1.15 [0.4;3.28]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Gestational age at delivery <37 weeks		RR:1.04 [0.64;1.69]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	High birth weight		RR:0.58 [-1.25;2.41]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Low birth weight		RR:2.75 [0.12;5.39]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Low birth weight		Adj OR:2.65 [1.3;5.76]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	3rd Tr	Small for gestational age		RR:1.83 [-3;6.66]
Wainstock, T (Sep, 2021)	Israel (EUR)	Comparative Cohort	913	General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Respiratory distress in the newborn		Adj OR:0.88 [0.44;1.79]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age		Adj OR:0.79 [0.48;1.31]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Small for gestational age		OR:0.66 [0.4;1.07]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Small for gestational age		OR:1.21 [0.56;2.64]
Woestenberg, P (Nov, 2023)	Netherlands (EUR)	Comparative Cohort	795	General pregnant population vaccinated	Nonspecified	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects	0.00	Adj OR:0.78 [0.35;1.71]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	1st Tr	Any congenital malformation(s) or birth defects	0.00	OR:0.94 [0.42;1.89]
Sakhvidi, M.Z. (Sep, 2023)	Iran;Islamic Rep. ()	Comparative Cohort	720	General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	0.00	Adj RR:0.87 [0.17;4.3]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	0.00	Adj RR:1 [NA;NA]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	0.00	Adj RR:0.94 [0.6;1.47]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	0.00	Adj RR:0.6 [0.28;1.33]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Low birth weight	0.00	Adj RR:0.68 [0.45;1.05]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Low birth weight	0.00	Adj RR:0.68 [0.35;1.31]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Low birth weight	0.00	Adj RR:0.95 [0.47;1.88]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age	0.00	Adj RR:0.83 [0.56;1.24]
				General pregnant population vaccinated	SIN	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age	0.00	Adj RR:0.58 [0.29;1.16]
				General pregnant population vaccinated	SIN	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	0.00	Adj RR:1 [NA;NA]
				General pregnant population vaccinated	SIN	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	0.00	Adj RR:0.63 [0.29;1.41]
				General pregnant population vaccinated	SIN	Versus other COVID-19 vaccine exposure	2nd Tr; 3rd Tr	Small for gestational age	0.00	Adj RR:0.94 [0.35;1.07]
Rottenstreich, M (Oct, 2021)	Israel (EUR)	Comparative Cohort	712	General pregnant population vaccinated	Pfz	Unvaccinated	3rd Tr	Composite adverse neonatal outcome		Adj OR:0.5 [0.36;0.74]
Pandit, NB (Sep, 2023)	India (SEAR)	Comparative Cohort	531	General pregnant population vaccinated	AZDi BBV	Unvaccinated	Global	Any congenital malformation(s) or birth defects	0.00	RR:0.54 [0.15;1.86]
				General pregnant population vaccinated	AZDi BBV	Unvaccinated	Global	Gestational age at delivery <37 weeks	0.00	RR:0.62 [0.45;0.85]
				General pregnant population vaccinated	AZDi BBV	Unvaccinated	Global	Low birth weight	0.00	RR:1.02 [0.9;1.15]
				General pregnant population vaccinated	AZDi BBV	Unvaccinated	Global	NICU hospitalization	0.92	RR:0.69 [0.5;0.96]
Ibroci, E. (Dec, 2022)	United States (AMR)	Comparative Cohort	250	General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	Global	NICU hospitalization		Adj RR:0.9 [0.5;1.7]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	1st Tr	NICU hospitalization		Adj RR:1.3 [0.5;3.7]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	2nd Tr	NICU hospitalization		Adj RR:1 [0.5;2.2]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	3rd Tr	NICU hospitalization		Adj RR:0.8 [0.4;1.8]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated; vaccinated after pregnancy	Global	NICU hospitalization		RR:1 [0.7;1.6]
Dizdar, M. (Jan, 2024)	Turkey (EUR)	Comparative Cohort	212	General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Any congenital malformation(s) or birth defects	0.00	Adj OR:0.68 [0.43;1.15]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	NICU hospitalization	0.92	Adj OR:1.21 [0.87;1.76]
				General pregnant population vaccinated	Pfz CRV	Unvaccinated	Global	Respiratory distress in the newborn	0.00	Adj OR:0.54 [0.22;1.09]
Blakeway, H (Aug, 2021)	United Kingdom (EUR)	Comparative Cohort	133	General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	Unvaccinated	2nd Tr; 3rd Tr	Any congenital malformation(s) or birth defects		Adj OR:0.89 [0.24;3.31]
				General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	Unvaccinated	2nd Tr; 3rd Tr	NICU hospitalization		Adj OR:1.05 [0.43;2.54]
				General pregnant population vaccinated; Pregnant people with risk factors; Advanced maternal age; Health workers	Mod Pfz AZD	Unvaccinated	2nd Tr; 3rd Tr	Small for gestational age		Adj OR:1 [0.55;1.82]
Eid, J. (Jul, 2022)	United States (AMR)	Comparative Cohort	125	Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Any congenital malformation(s) or birth defects		Adj OR:0.44 [0.02;2.6]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Gestational age at delivery <37 weeks		Adj OR:0.55 [0.25;1.04]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	NICU hospitalization		Adj OR:0.57 [0.19;1.42]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Small for gestational age		Adj OR:0.72 [0.26;1.77]
Nguanboonmak, A (May, 2023)	Thailand (SEAR)	Comparative Cohort	99	General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Birth asphyxia		OR:0.52 [0.17;1.55]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Gestational age at delivery <37 weeks		OR:1.17 [0.69;1.96]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Low birth weight		OR:0.55 [0.23;1.29]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	NICU hospitalization		OR:0.68 [0.45;0.98]
Li, M. (Dec, 2022)	China (WPR)	Comparative Cohort	93	General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	Unvaccinated	1st Tr	Phototherapy		OR:3.167 [1.459;6.872]
				General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	Unvaccinated	1st Tr	Phototherapy		Adj OR:2.888 [1.167;7.145]
Kammoun, M (Dec, 2023)	Tunisia (EMR)	Comparative Cohort	59	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Versus other COVID-19 vaccine exposure; Active or previous SARS-COV-2 infection	Global	Gestational age at delivery <32 weeks	0.00	OR:0.278 [0.07;1.07]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Versus other COVID-19 vaccine exposure; Active or previous SARS-COV-2 infection	Global	Gestational age at delivery <37 weeks	0.00	OR:0.19 [0.06;0.91]
Peretz-Machluf, R (Jan, 2024)	Israel (EUR)	Cross-sectional	223	General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	Non-specified	Gestational age at delivery <37 weeks	0.00	Adj OR:0.57 [0.086;3.84]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	Non-specified	NICU hospitalization		Adj OR:2.04 [0.383;10.9]
				General pregnant population vaccinated	Pfz	Versus other COVID-19 vaccine exposure	Non-specified	Respiratory distress in the newborn		Adj OR:1.1 [0.186;6.44]
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered
dICU, intensive care unit; NICU, neonatal intensive care unit

Non-Comparative measure

Analysis unit: Persons

Table 7: Study characteristics and main results from studies that assessed infant safety outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Exposed study population	Vaccine product (Dose)b	Trimester of vaccine exposurec	Outcomed	Primary result
Jorgensen S. (Oct, 2023)	Canada (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	4826/85670 (5.63%)
			General pregnant population vaccinated	Mod Pfz	Global	Low birth weight	4139/85670 (4.83%)
Shimabukuro, T. T. (Jun, 2021)	United States (AMR)	Non-comparative Cohort	Health workers; live-born infants	Mod Pfz	Global	Any congenital malformation(s) or birth defects	16/724 (2.21%)
			Health workers; live-born infants	Mod Pfz	Global	Neonatal death	0/724 (0.00%)
			Health workers; live-born infants	Mod Pfz	Global	Small for gestational age	23/724 (3.18%)
			Health workers; vaccinated before 37 weeks of gestation	Mod Pfz	Global	Gestational age at delivery <37 weeks	60/636 (9.43%)
Magnus, M.C. (Mar, 2022)	Sweden, Norway (EUR)	Comparative Cohort	General pregnant population vaccinated	AZD	Global	Apgar score < 7 at five minutes	9/475 (1.89%)
			General pregnant population vaccinated	AZD	Global	Gestational age at delivery <37 weeks	18/475 (3.79%)
			General pregnant population vaccinated	AZD	Global	NICU hospitalization	46/475 (9.68%)
			General pregnant population vaccinated	AZD	Global	Small for gestational age	44/475 (9.26%)
			General pregnant population vaccinated	Mod Pfz AZD	1st Tr	Apgar score < 7 at five minutes	22/1125 (1.96%)
			General pregnant population vaccinated	Mod Pfz AZD	1st Tr	Gestational age at delivery <37 weeks	60/1125 (5.33%)
			General pregnant population vaccinated	Mod Pfz AZD	1st Tr	NICU hospitalization	119/1125 (10.58%)
			General pregnant population vaccinated	Mod Pfz AZD	1st Tr	Small for gestational age	96/1125 (8.53%)
Changizi, N. (Sep, 2023)	Iran;Islamic Rep. ()	Comparative Cohort	General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Global	NICU hospitalization	41/1096 (3.74%)
Ki Hoon, A (Aug, 2022)	Korea;Rep. (WPR)	Comparative Cohort Cross-sectional	Non-specified	AZD	Global	Gestational age at delivery <37 weeks	2/1135 (0.18%)
			Non-specified	J&J	Global	Gestational age at delivery <37 weeks	0/439 (0.00%)
			Non-specified	Mod	Global	Gestational age at delivery <37 weeks	0/1734 (0.00%)
			Non-specified	Mod Pfz J&J AZD	Global	Gestational age at delivery <37 weeks	3/13440 (0.02%)
			Non-specified	Pfz	Global	Gestational age at delivery <37 weeks	0/10132 (0.00%)
Reefhuis, J (-)	United States (AMR)	Cross-sectional	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz J&J	Global	Any congenital malformation(s) or birth defects	331/10011 (3.31%)
Goldshtein, I (Jul, 2021)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	77/1387 (5.55%)
Darwin, K (Aug, 2023)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz J&J	Non-specified	Gestational age at delivery <37 weeks	165/1782 (9.26%)
			General pregnant population vaccinated	Pfz	Non-specified	Neonatal death	7/3462 (0.20%)
			General pregnant population vaccinated	Pfz	Non-specified	NICU hospitalization	485/3462 (14.01%)
Peretz-Machluf, R (Apr, 2022)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	10/3240 (0.31%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Hypoglycemia	159/3240 (4.91%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Hypothermia	1/3240 (0.03%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Intracranial hemorrhage	1/3240 (0.03%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Neonatal invasive ventilation	27/3240 (0.83%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Respiratory distress in the newborn	17/3240 (0.52%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Transient tachypnea	40/3240 (1.23%)
Mcclymont, E. (Feb, 2023)	Canada (AMR)	Comparative Cohort	General pregnant population vaccinated	Nonspecified	Non-specified	Gestational age at delivery <37 weeks	171/3050 (5.61%)
			General pregnant population vaccinated	Nonspecified	Non-specified	NICU hospitalization	320/3050 (10.49%)
McClymont E. (Oct, 2023)	Canada (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz J&J AZD	Global	Low birth weight	124/2830 (4.38%)
			General pregnant population vaccinated	Mod Pfz J&J AZD	Global	Neonatal invasive ventilation	166/2830 (5.87%)
			General pregnant population vaccinated	Mod Pfz J&J AZD	Global	NICU hospitalization	279/2830 (9.86%)
Dick, A (Feb, 2022)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	2nd Tr	Apgar score < 7 at five minutes	16/964 (1.66%)
			General pregnant population vaccinated	Mod Pfz	3rd Tr	Apgar score < 7 at five minutes	20/1329 (1.50%)
Rottenstreich, M. (Sep, 2022)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Apgar score < 7 at five minutes	16/626 (2.56%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	Neonatal invasive ventilation	1/626 (0.16%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-specified	NICU hospitalization	0/626 (0.00%)
Santos, J (Apr, 2024)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz J&J	Global	Any congenital malformation(s) or birth defects	225/1176 (19.13%)
			General pregnant population vaccinated	Mod Pfz J&J	Global	NICU hospitalization	98/1176 (8.33%)
			General pregnant population vaccinated	Mod Pfz J&J	1st Tr	NICU hospitalization	27/319 (8.46%)
			General pregnant population vaccinated	Mod Pfz J&J	Global	Small for gestational age	87/1176 (7.40%)
Vuong, L.N. (May, 2022)	Vietnam (WPR)	Comparative Cohort	General pregnant population vaccinated	Pfz	3rd Tr	Any congenital malformation(s) or birth defects	4/513 (0.78%)
			General pregnant population vaccinated	Pfz	3rd Tr	Gestational age at delivery <28 weeks	0/513 (0.00%)
			General pregnant population vaccinated	Pfz	3rd Tr	NICU hospitalization	23/513 (4.48%)
Kugelman, N. (Nov, 2022)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	7/930 (0.75%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Gestational age at delivery 32-36 weeks	12/930 (1.29%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Low birth weight	43/930 (4.62%)
			General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	NICU hospitalization	43/930 (4.62%)
Wainstock, T (Sep, 2021)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	2/913 (0.22%)
			General pregnant population vaccinated	Pfz	Non-specified	Respiratory distress in the newborn	3/155 (1.94%)
			General pregnant population vaccinated	Pfz	Non-specified	Respiratory distress in the newborn	11/758 (1.45%)
Sakhvidi, M.Z. (Sep, 2023)	Iran;Islamic Rep. ()	Comparative Cohort	General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	Any congenital malformation(s) or birth defects	0/558 (0.00%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	Any congenital malformation(s) or birth defects	0/162 (0.00%)
Rottenstreich, M (Oct, 2021)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	3rd Tr	Apgar score < 7 at five minutes	21/712 (2.95%)
			General pregnant population vaccinated	Pfz	3rd Tr	Birth asphyxia	1/712 (0.14%)
			General pregnant population vaccinated	Pfz	3rd Tr	Gestational age at delivery <37 weeks	27/712 (3.79%)
			General pregnant population vaccinated	Pfz	3rd Tr	Hypoglycemia	12/712 (1.69%)
			General pregnant population vaccinated	Pfz	3rd Tr	Intracranial hemorrhage	0/712 (0.00%)
			General pregnant population vaccinated	Pfz	3rd Tr	Neonatal encephalopathy	0/712 (0.00%)
			General pregnant population vaccinated	Pfz	3rd Tr	Neonatal invasive ventilation	4/712 (0.56%)
			General pregnant population vaccinated	Pfz	3rd Tr	NICU hospitalization	29/712 (4.07%)
			General pregnant population vaccinated	Pfz	3rd Tr	Phototherapy	16/712 (2.25%)
			General pregnant population vaccinated	Pfz	3rd Tr	Seizure	1/712 (0.14%)
			General pregnant population vaccinated	Pfz	3rd Tr	Sepsis	1/712 (0.14%)
			General pregnant population vaccinated	Pfz	3rd Tr	Small for gestational age	81/712 (11.38%)
			General pregnant population vaccinated	Pfz	3rd Tr	Transient tachypnea	3/712 (0.42%)
Chau, M.N. (Mar, 2023)	Vietnam (WPR)	Comparative Cohort	General pregnant population vaccinated	Pfz	2nd Tr; 3rd Tr	Low birth weight	21/267 (7.87%)
Pandit, NB (Sep, 2023)	India (SEAR)	Comparative Cohort	General pregnant population vaccinated	AZDi	Global	Any congenital malformation(s) or birth defects	3/511 (0.59%)
			General pregnant population vaccinated	AZDi	Global	Gestational age at delivery <37 weeks	42/511 (8.22%)
			General pregnant population vaccinated	AZDi	Global	Low birth weight	202/511 (39.53%)
			General pregnant population vaccinated	AZDi	Global	NICU hospitalization	37/511 (7.24%)
			General pregnant population vaccinated	BBV	Global	Any congenital malformation(s) or birth defects	0/20 (0.00%)
			General pregnant population vaccinated	BBV	Global	Gestational age at delivery <37 weeks	0/20 (0.00%)
			General pregnant population vaccinated	BBV	Global	Low birth weight	10/20 (50.00%)
			General pregnant population vaccinated	BBV	Global	NICU hospitalization	6/20 (30.00%)
Cardemil, C (Mar, 2024)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	22/204 (10.78%)
			General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	19/271 (7.01%)
			General pregnant population vaccinated	Mod Pfz	Global	Low birth weight	19/204 (9.31%)
			General pregnant population vaccinated	Mod Pfz	Global	Low birth weight	20/271 (7.38%)
Trostle, ME (Aug, 2021)	United States (AMR)	Cross-sectional	General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Any congenital malformation(s) or birth defects	2/85 (2.35%)
			General pregnant population vaccinated	Mod Pfz	Global	Any congenital malformation(s) or birth defects	5/327 (1.53%)
			General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	5/85 (5.88%)
			General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Neonatal death	0/85 (0.00%)
			General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	NICU hospitalization	13/85 (15.29%)
			General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Small for gestational age	10/85 (11.76%)
Du, T. (Oct, 2023)	China (WPR)	Non-comparative Cohort	General pregnant population vaccinated	SIN CRV	1st Tr	Any congenital malformation(s) or birth defects	7/326 (2.15%)
			General pregnant population vaccinated	SIN CRV	1st Tr	Apgar score < 7 at five minutes	6/326 (1.84%)
			General pregnant population vaccinated	SIN CRV	1st Tr	Gestational age at delivery <37 weeks	40/326 (12.27%)
			General pregnant population vaccinated	SIN CRV	1st Tr	Low birth weight	6/326 (1.84%)
Ghesquiere, L. (Nov, 2023)	Canada (AMR)	Non-comparative Cohort	General pregnant population vaccinated	Nonspecified	1st Tr	Gestational age at delivery <37 weeks	1/88 (1.14%)
			General pregnant population vaccinated	Nonspecified	2nd Tr	Gestational age at delivery <37 weeks	8/140 (5.71%)
			General pregnant population vaccinated	Nonspecified	3rd Tr	Gestational age at delivery <37 weeks	3/24 (12.50%)
			General pregnant population vaccinated	Nonspecified	1st Tr	Low birth weight	5/88 (5.68%)
			General pregnant population vaccinated	Nonspecified	2nd Tr	Low birth weight	13/140 (9.29%)
			General pregnant population vaccinated	Nonspecified	3rd Tr	Low birth weight	4/24 (16.67%)
Ibroci, E. (Dec, 2022)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	16/250 (6.40%)
			General pregnant population vaccinated	Mod Pfz	Global	Small for gestational age	23/250 (9.20%)
Abu Shqara, R (Jun, 2023)	Israel (EUR)	Cross-sectional	General pregnant population vaccinated	Pfz	Global	Apgar score < 7 at five minutes	1/238 (0.42%)
Süt H. (Jun, 2023)	Turkey (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz CRV	Global	Gestational age at delivery <37 weeks	13/236 (5.51%)
			General pregnant population vaccinated	Pfz CRV	Global	Neonatal death	0/236 (0.00%)
			General pregnant population vaccinated	Pfz CRV	Global	NICU hospitalization	23/236 (9.75%)
Peretz-Machluf, R (Jan, 2024)	Israel (EUR)	Cross-sectional	General pregnant population vaccinated	Pfz	Non-specified	Apgar score < 7 at five minutes	1/84 (1.19%)
			General pregnant population vaccinated	Pfz	Non-specified	Neonatal invasive ventilation	1/84 (1.19%)
Cahen-Peretz, A. (Jan, 2023)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global	Apgar score < 7 at five minutes	4/86 (4.65%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global	Gestational age at delivery <37 weeks	9/86 (10.47%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Global	NICU hospitalization	4/86 (4.65%)
Dizdar, M. (Jan, 2024)	Turkey (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	1st Tr	Any congenital malformation(s) or birth defects	1/8 (12.50%)
			General pregnant population vaccinated	Pfz	1st Tr	NICU hospitalization	4/8 (50.00%)
			General pregnant population vaccinated	Pfz CRV	2nd Tr	Any congenital malformation(s) or birth defects	7/82 (8.54%)
			General pregnant population vaccinated	Pfz CRV	3rd Tr	Any congenital malformation(s) or birth defects	4/122 (3.28%)
			General pregnant population vaccinated	Pfz CRV	Global	Gestational age at delivery <37 weeks	6/212 (2.83%)
			General pregnant population vaccinated	Pfz CRV	2nd Tr	NICU hospitalization	27/82 (32.93%)
			General pregnant population vaccinated	Pfz CRV	3rd Tr	NICU hospitalization	18/122 (14.75%)
Zilver, S.J.M. (Feb, 2023)	Netherlands (EUR)	Non-comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	1/130 (0.77%)
			General pregnant population vaccinated	Mod Pfz	Global	NICU hospitalization	11/130 (8.46%)
(-)	United Kingdom, Spain, South Africa, Brazil, United States (EUR AMR AFR)	Controlled clinical trial	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Any congenital malformation(s) or birth defects	10/167 (5.99%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Gestational age at delivery <37 weeks	0/161 (0.00%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Low birth weight	0/161 (0.00%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	3rd Tr	Respiratory distress in the newborn	0/161 (0.00%)
Citu, IM (Feb, 2022)	Romania (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz J&J	3rd Tr	Abnormal fetal monitoring	11/173 (6.36%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr	Apgar score < 7 at five minutes	2/173 (1.16%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr	Gestational age at delivery <37 weeks	14/173 (8.09%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr	Meconium aspiration	7/173 (4.05%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr	Respiratory distress in the newborn	1/173 (0.58%)
			General pregnant population vaccinated	Pfz J&J	3rd Tr	Small for gestational age	6/173 (3.47%)
Smithgall, M (Nov, 2022)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-specified	Apgar score < 7 at five minutes	2/164 (1.22%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-specified	Gestational age at delivery <37 weeks	15/164 (9.15%)
			General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-specified	Small for gestational age	26/164 (15.85%)
Theiler, R N (Aug, 2021)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	3/140 (2.14%)
			General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	Gestational age at delivery <32 weeks	3/140 (2.14%)
			General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	Gestational age at delivery 32-36 weeks	10/140 (7.14%)
			General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	Low birth weight	11/140 (7.86%)
			General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	NICU hospitalization	1/140 (0.71%)
			General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	Perinatal death (during delivery)	0/140 (0.00%)
			General pregnant population vaccinated	Mod Pfz J&J	2nd Tr; 3rd Tr	Very low birth weight	3/140 (2.14%)
Moro, P (Apr, 2024)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	6/136 (4.41%)
			General pregnant population vaccinated	Mod Pfz	Global	Low birth weight	2/136 (1.47%)
			General pregnant population vaccinated	Mod Pfz	Global	NICU hospitalization	3/136 (2.21%)
Tripathy, G (Jul, 2023)	India (SEAR)	Comparative Cohort	General pregnant population vaccinated	AZDi BBV	Global	Apgar score 1 min score <7	15/125 (12.00%)
			General pregnant population vaccinated	AZDi BBV	Global	Gestational age at delivery <32 weeks	6/127 (4.72%)
			General pregnant population vaccinated	AZDi BBV	Global	Gestational age at delivery <37 weeks	17/127 (13.39%)
			General pregnant population vaccinated	AZDi BBV	1st Tr	Gestational age at delivery <37 weeks	3/27 (11.11%)
			General pregnant population vaccinated	AZDi BBV	2nd Tr	Gestational age at delivery <37 weeks	8/51 (15.69%)
			General pregnant population vaccinated	AZDi BBV	3rd Tr	Gestational age at delivery <37 weeks	6/49 (12.24%)
			General pregnant population vaccinated	AZDi BBV	Global	NICU hospitalization	25/127 (19.69%)
			General pregnant population vaccinated	AZDi BBV	1st Tr	NICU hospitalization	2/27 (7.41%)
			General pregnant population vaccinated	AZDi BBV	2nd Tr	NICU hospitalization	9/51 (17.65%)
			General pregnant population vaccinated	AZDi BBV	3rd Tr	NICU hospitalization	14/49 (28.57%)
Arulappen, A.L. (May, 2022)	Malaysia (WPR)	Non-comparative Cohort	Health workers	Pfz	Global	Constipation	1/120 (0.83%)
			Health workers	Pfz	Global	Gestational age at delivery <37 weeks	14/120 (11.67%)
			Health workers	Pfz	Global	Neonatal death	0/120 (0.00%)
			Health workers	Pfz	Global	NICU hospitalization	27/120 (22.50%)
			Health workers	Pfz	Global	Phototherapy	103/120 (85.83%)
			Health workers	Pfz	Global	Sepsis	14/120 (11.67%)
			Health workers	Pfz	Global	Small for gestational age	7/120 (5.83%)
Ling, L. (Aug, 2023)	China (WPR)	Comparative Cohort	General pregnant population vaccinated	SIN	1st Tr	Birth asphyxia	0/105 (0.00%)
			General pregnant population vaccinated	SIN	1st Tr	Gestational age at delivery <37 weeks	1/105 (0.95%)
			General pregnant population vaccinated	SIN	1st Tr	High birthweight	1/105 (0.95%)
			General pregnant population vaccinated	SIN	1st Tr	Intrauterine fetal death or induction of labor	2/105 (1.90%)
			General pregnant population vaccinated	SIN	1st Tr	NICU hospitalization	4/105 (3.81%)
			General pregnant population vaccinated	SIN	1st Tr	Small for gestational age	1/105 (0.95%)
Otero, S (Jan, 2023)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	5/99 (5.05%)
Li, M. (Dec, 2022)	China (WPR)	Comparative Cohort	General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Any congenital malformation(s) or birth defects	2/93 (2.15%)
			General pregnant population vaccinated; received COVID‐19 vaccine within 3 months before their last menstruation period (n:66)	SIN CRV	1st Tr	Gestational age at delivery <37 weeks	8/93 (8.60%)
Popescu, D (Feb, 2024)	Romania (EUR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz J&J	Global	Any congenital malformation(s) or birth defects	2/91 (2.20%)
			General pregnant population vaccinated	Mod Pfz J&J	Global	Neonatal encephalopathy	6/91 (6.59%)
Popescu, D. (May, 2022)	Romania (EUR)	Comparative Cohort	General pregnant population vaccinated; COVID-19 disease during pregnancy before vaccine	Pfz	Global	Apgar score < 7 at five minutes	1/91 (1.10%)
			General pregnant population vaccinated; COVID-19 disease during pregnancy before vaccine	Pfz	Global	Gestational age at delivery <37 weeks	4/91 (4.40%)
Cassidy, A (Jul, 2023)	United States (AMR)	Non-comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Any congenital malformation(s) or birth defects	4/76 (5.26%)
			General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	4/76 (5.26%)
			General pregnant population vaccinated	Mod Pfz	Global	NICU hospitalization	11/76 (14.47%)
			General pregnant population vaccinated	Mod Pfz	Global	Small for gestational age	2/76 (2.63%)
			General pregnant population vaccinated	Pfz	Global	Any congenital malformation(s) or birth defects	1/42 (2.38%)
			General pregnant population vaccinated	Pfz	Global	Gestational age at delivery <37 weeks	0/42 (0.00%)
			General pregnant population vaccinated	Pfz	Global	NICU hospitalization	5/42 (11.90%)
			General pregnant population vaccinated	Pfz	Global	Small for gestational age	1/42 (2.38%)
Maguire, S. (Sep, 2022)	Ireland (EUR)	Cross-sectional	Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	COVID-19 infection led to birth	1/26 (3.85%)
			Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Gestational age at delivery <37 weeks	2/26 (7.69%)
			Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Low birth weight	3/26 (11.54%)
			Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	NICU hospitalization	0/26 (0.00%)
			Previous SARS-CoV-2 infection; Women with rheumatic and musculoskeletal diseases (RMDs) who developed COVID-19 during pregnancy	Nonspecified	Non-specified	Small for gestational age	2/26 (7.69%)
Hillson, K. (Oct, 2021)	South Africa, Brazil, United Kingdom (EUR AMR AFR)	Comparative Cohort	General pregnant population vaccinated	AZD	1st Tr	Gestational age at delivery <37 weeks	3/10 (30.00%)
Sourouni, M (May, 2022)	Germany (EUR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Any congenital malformation(s) or birth defects	0/57 (0.00%)
Jarraya, A (Dec, 2023)	Tunisia (EMR)	Comparative Cohort	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Gestational age at delivery <28 weeks	1/59 (1.69%)
			General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Gestational age at delivery <32 weeks	11/59 (18.64%)
			General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Neonatal death	0/59 (0.00%)
			General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	NICU hospitalization	4/59 (6.78%)
Kammoun, M (Dec, 2023)	Tunisia (EMR)	Comparative Cohort	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Gestational age at delivery <28 weeks	0/41 (0.00%)
			General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	Neonatal death	0/41 (0.00%)
			General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Global	NICU hospitalization	0/41 (0.00%)
Santos, A. (Mar, 2022)	United States (AMR)	Non-comparative Cohort	General pregnant population vaccinated	Mod Pfz	Non-specified	Any congenital malformation(s) or birth defects	3/48 (6.25%)
			General pregnant population vaccinated	Mod Pfz	Non-specified	Gestational age at delivery <28 weeks	2/48 (4.17%)
			General pregnant population vaccinated	Mod Pfz	Non-specified	Gestational age at delivery <37 weeks	13/48 (27.08%)
Kim, H. (Mar, 2023)	Korea;Rep. (WPR)	Comparative Cohort	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Non-specified	Gestational age at delivery <37 weeks	0/39 (0.00%)
Kadali, R. A. K (Oct, 2021)	United States (AMR)	Cross-sectional	Health workers	Mod	Non-specified	Gestational age at delivery <37 weeks	0/18 (0.00%)
			Health workers	Mod Pfz	Non-specified	Gestational age at delivery <37 weeks	1/38 (2.63%)
			Health workers	Pfz	Non-specified	Gestational age at delivery <37 weeks	1/20 (5.00%)
Dude, C (Jan, 2023)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks	2/34 (5.88%)
Kashani-Ligumsky,L (Sep, 2021)	Israel (EUR)	Comparative Cohort	General pregnant population vaccinated	Pfz	3rd Tr	Gestational age at delivery <37 weeks	0/29 (0.00%)
Sabharwal, V. (Oct, 2023)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Pfz	Global	NICU hospitalization	3/25 (12.00%)
Hantoushzadeh, S (Jun, 2023)	Iran;Islamic Rep. ()	Non-comparative Cohort	General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	Apgar score < 7 at five minutes	0/23 (0.00%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	Gestational age at delivery <37 weeks	1/23 (4.35%)
			General pregnant population vaccinated	SIN	2nd Tr; 3rd Tr	NICU hospitalization	1/23 (4.35%)
Juttukonda, L. J (Sep, 2022)	United States (AMR)	Comparative Cohort	General pregnant population vaccinated	Mod Pfz	1st Tr	NICU hospitalization	0/17 (0.00%)
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered
dICU, intensive care unit; NICU, neonatal intensive care unit

Analysis unit: Total number of AEs reported

Table 8: Study characteristics and main results from studies that assessed infant safety outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Exposed study population	Vaccine product (Dose)b	Trimester of vaccine exposurec	Outcomed		Primary result
Moro, P.L. (Aug, 2022)	United States (AMR)	Non-comparative Cohort	General pregnant population vaccinated	Mod	Global	Any congenital malformation(s) or birth defects		1/145 (0.69%)
			General pregnant population vaccinated	Mod	Global	Gestational age at delivery <37 weeks		1/145 (0.69%)
			General pregnant population vaccinated	Mod	Global	included two reports of fetal tachycardia and one report each of a heart defect and small for gestational age.		1/145 (0.69%)
			General pregnant population vaccinated	Mod	Global	Neonatal death		0/145 (0.00%)
			General pregnant population vaccinated	Mod	Global	NICU hospitalization		1/145 (0.69%)
			General pregnant population vaccinated	Mod Pfz	Global	Any congenital malformation(s) or birth defects		2/323 (0.62%)
			General pregnant population vaccinated	Mod Pfz	Global	Gestational age at delivery <37 weeks		2/323 (0.62%)
			General pregnant population vaccinated	Mod Pfz	Global	included two reports of fetal tachycardia and one report each oa heart defect and small for gestational age.		4/323 (1.24%)
			General pregnant population vaccinated	Mod Pfz	Global	Neonatal death		1/323 (0.31%)
			General pregnant population vaccinated	Mod Pfz	Global	NICU hospitalization		3/323 (0.93%)
			General pregnant population vaccinated	Pfz	Global	Any congenital malformation(s) or birth defects		1/178 (0.56%)
			General pregnant population vaccinated	Pfz	Global	Gestational age at delivery <37 weeks		1/178 (0.56%)
			General pregnant population vaccinated	Pfz	Global	included two reports of fetal tachycardia and one report each of a heart defect and small for gestational age.		3/178 (1.69%)
			General pregnant population vaccinated	Pfz	Global	Neonatal death		1/178 (0.56%)
			General pregnant population vaccinated	Pfz	Global	NICU hospitalization		2/178 (1.12%)
Moro,PL (Apr, 2022)	United States (AMR)	Non-comparative Cohort	Non-specified	J&J	Global	Any congenital malformation(s) or birth defects		0/275 (0.00%)
			Non-specified	J&J	Global	Gestational age at delivery <37 weeks		3/275 (1.09%)
			Non-specified	J&J	Global	Neonatal death		2/275 (0.73%)
			Non-specified	J&J	Global	NICU hospitalization		1/275 (0.36%)
			Non-specified	Mod	Global	Any congenital malformation(s) or birth defects		15/1350 (1.11%)
			Non-specified	Mod	Global	Gestational age at delivery <37 weeks		25/1350 (1.85%)
			Non-specified	Mod	Global	Neonatal death		1/1350 (0.07%)
			Non-specified	Mod	Global	NICU hospitalization		10/1350 (0.74%)
			Non-specified	Mod Pfz J&J	Global	Any congenital malformation(s) or birth defects		26/3462 (0.75%)
			Non-specified	Mod Pfz J&J	Global	Gestational age at delivery <37 weeks		76/3462 (2.20%)
			Non-specified	Mod Pfz J&J	Global	Neonatal death		12/3462 (0.35%)
			Non-specified	Mod Pfz J&J	Global	NICU hospitalization		21/3462 (0.61%)
			Non-specified	Pfz	Global	Any congenital malformation(s) or birth defects		11/1831 (0.60%)
			Non-specified	Pfz	Global	Gestational age at delivery <37 weeks		48/1831 (2.62%)
			Non-specified	Pfz	Global	Neonatal death		9/1831 (0.49%)
			Non-specified	Pfz	Global	NICU hospitalization		10/1831 (0.55%)
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered
dICU, intensive care unit; NICU, neonatal intensive care unit

Efficacy/Effectiveness outcomes

Comparative measure

Table 9: Study characteristics and main results from studies that assessed efficacy/effectiveness outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Exposed study population	Vaccine product (Dose)b	Comparator	Trimester of vaccine exposurec	SARS-CoV-2 Variant	Minimun time after vaccine exposure	Maximum time after vaccine exposure	Outcome in Mother or Infant	Months after birth	Outcome	Primary result
Guedalia J (Nov, 2022)	Israel (EUR)	Comparative Cohort	52,193	General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Mother		COVID-19 Severe disease	VE:99 [89;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Mother		COVID-19 Severe disease	VE:96 [86;99]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Mother		COVID-19 Significant disease	VE:99 [93;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Mother		COVID-19 Significant disease	VE:97 [92;99]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	VE:97 [95;99]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	VE:61 [51;69]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		COVID-19 Severe disease	VE:94 [43;99]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		COVID-19 Severe disease	VE:83 [-47;98]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		COVID-19 Significant disease	VE:97 [72;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		COVID-19 Significant disease	VE:51 [-47;84]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	VE:43 [31;53]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	VE:-12 [-36;8]
Changizi, N. (Sep, 2023)	Iran;Islamic Rep. ()	Comparative Cohort	19,922	General pregnant population vaccinated	AZD SIN SpV Other		Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.65 [0.62;0.67]
				General pregnant population vaccinated	SIN	Unvaccinated	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.63 [0.6;0.65]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:2.82 [0.04;221.58]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.63 [0.46;0.84]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.21 [0.01;1.21]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:0.677 [0.448;1.024]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	Adj OR:0.69 [0.45;1.04]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.453 [0.382;0.535]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.65 [0.62;0.67]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	AZD SIN SpV Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.47 [0.39;0.55]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:2.82 [0.036;221.58]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.557 [0.387;0.787]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Other	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.297 [0.007;1.758]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	SIN	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:0.67 [0.44;1.08]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	SIN	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.47 [0.39;0.56]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	SpV	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:1.41 [0.024;27.149]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	SpV	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.588 [0.392;0.862]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	SpV	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.744 [0.086;2.919]
Zerbo, O (Feb, 2023)	United States (AMR)	Comparative Cohort Case control	10,893	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	2.00	Virologically confirmed SARS-CoV-2 infection	VE:86 [71;93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	2.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:95 [76;99]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	VE:72 [57;81]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	VE:66 [52;76]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	VE:72 [24;89]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:70 [52;82]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:61 [42;74]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:76 [31;92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	2.00	Virologically confirmed SARS-CoV-2 infection	VE:29 [-4;51]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	2.00	Virologically confirmed SARS-CoV-2 infection	VE:51 [-72;93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	2.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:43 [-4;69]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	2.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:-27 [-91;84]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	VE:21 [1;37]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	VE:24 [-34;63]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:36 [11;55]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:36 [-50;80]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	VE:22 [9;33]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	VE:-1 [-34;33]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:41 [25;53]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:16 [-35;55]
Dagan, N (Sep, 2021)	Israel (EUR)	Comparative Cohort	10,861	General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	14	20	Mother		Symptomatic COVID-19	Adj VE:66 [32;86]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	14	20	Mother		Symptomatic COVID-19	Adj Risk Difference (per 100000 persons):223.59 [82.44;361.63]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	14	20	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:67 [40;84]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	14	20	Mother		Virologically confirmed SARS-CoV-2 infection	Adj Risk Difference (per 100000 persons):309.22 [145.43;485.69]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	21	27	Mother		Symptomatic COVID-19	Adj VE:76 [30;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	21	27	Mother		Symptomatic COVID-19	Adj Risk Difference (per 100000 persons):116.52 [26.92;217.92]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	21	27	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:71 [33;94]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	21	27	Mother		Virologically confirmed SARS-CoV-2 infection	Adj Risk Difference (per 100000 persons):157.3 [41.42;285.23]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	7	56	Mother		Severe COVID-19 - composite	Adj Risk Difference (per 100000 persons):132.28 [31.67;241.03]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	7	56	Mother		Severe COVID-19 - composite	Adj VE:89 [43;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	7	56	Mother		Symptomatic COVID-19	Adj VE:97 [91;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	7	56	Mother		Symptomatic COVID-19	Adj Risk Difference (per 100000 persons):621.7 [433.68;847.26]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	7	56	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:96 [89;100]
				General pregnant population vaccinated	Pfz	Unvaccinated	Global	Alpha Other	7	56	Mother		Virologically confirmed SARS-CoV-2 infection	Adj Risk Difference (per 100000 persons):933.4 [685.6;1192.33]
Florentino, P. (Nov, 2022)	Brazil (AMR)	Case control	10,786	General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	0	13	Mother		Severe COVID-19 - composite	Adj VE:43.2 [1.7;67.2]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	0	13	Mother		Symptomatic COVID-19	Adj VE:46.4 [33.2;57]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	14	120	Mother		Severe COVID-19 - composite	Adj VE:68.4 [52.6;78.9]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Omicron	14	120	Mother		Symptomatic COVID-19	Adj VE:37.7 [28.9;45.3]
Carlsen, EØ (Jun, 2022)	Norway (EUR)	Comparative Cohort	9,739	General pregnant population vaccinated	Nonspecified	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	320	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj HR:0.29 [0.19;0.45]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	320	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj HR:0.11 [0.03;0.43]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	2nd Tr; 3rd Tr	Omicron	14	320	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj HR:0.7 [0.59;0.83]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	2nd Tr; 3rd Tr	Omicron	14	320	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj HR:0.72 [0.5;1.03]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	2nd Tr; 3rd Tr	Omicron	14	320	Infant	4.00	Virologically confirmed SARS-CoV-2 infection	Adj HR:0.22 [0.12;0.43]
Goldshtein, I (Jul, 2021)	Israel (EUR)	Comparative Cohort	7,530	General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Alpha	0	70	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:0.22 [0.11;0.43]
Magnus, MC (Sep, 2022)	Norway (EUR)	Comparative Cohort	7,412	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	HR:0.98 [0.83;1.15]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:0.99 [0.83;1.2]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	HR:0.86 [0.73;1.02]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:0.98 [0.8;1.19]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	HR:0.9 [0.84;0.97]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta Omicron	14	210	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:0.99 [0.92;1.07]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	HR:0.92 [0.85;1]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:1.03 [0.94;1.12]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection; booster dose	Non-specified	Delta Omicron	14	40	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:1.24 [0.84;1.84]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Mod Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection; booster dose	Non-specified	Omicron	14	40	Mother		Virologically confirmed SARS-CoV-2 infection	HR:0.94 [0.65;1.35]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	HR:0.94 [0.85;1.04]
				General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Non-pregnant; Non-previous SARS-CoV-2 infection	2nd Tr; 3rd Tr	Delta Omicron	14	180	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:1.04 [0.93;1.16]
Goh, O (Nov, 2023)	Singapore (WPR)	Comparative Cohort	6,542	General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:41.5 [22.8;55.7]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:37.6 [17.2;53.1]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:44.4 [26.2;58.1]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Omicron Other	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:74.8 [5.7;93.2]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Omicron Other	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:73 [-30.6;94.4]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Global	Omicron Other	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:76.7 [12.8;93.8]
Jorgensen, S. C. J. (Feb, 2023)	Canada (AMR)	Case control	5,516	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Severe COVID-19 - composite	Adj VE:97 [73;100]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:95 [88;98]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	1.85	Virologically confirmed SARS-CoV-2 infection	Adj VE:57 [44;66]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	3.70	Virologically confirmed SARS-CoV-2 infection	Adj VE:47 [61;60]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Severe COVID-19 - composite	Adj VE:53 [39;64]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Severe COVID-19 - composite	Adj VE:80 [64;89]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:45 [37;53]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:73 [61;80]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:47 [31;59]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:37 [24;47]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	3rd Tr	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:53 [42;62]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj VE:40 [21;54]
Lapinsky, S (Oct, 2023)	Canada (AMR)	Case control	5,305	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	0	2	Mother		Symptomatic COVID-19	Adj OR:0.39 [0.29;0.53]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	0	2	Mother		Symptomatic COVID-19	VE:61 [47;71]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	2	4	Mother		Symptomatic COVID-19	Adj OR:0.53 [0.39;0.71]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	2	4	Mother		Symptomatic COVID-19	VE:47 [29;61]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	4	6	Mother		Symptomatic COVID-19	Adj OR:0.71 [0.58;0.86]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	4	6	Mother		Symptomatic COVID-19	VE:29 [14;42]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	6	Nonspecified	Mother		Symptomatic COVID-19	Adj OR:0.72 [0.55;0.93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	6	Nonspecified	Mother		Symptomatic COVID-19	VE:28 [7;45]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	VE:85 [72;92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.15 [0;0.2]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	VE:85 [72;92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	VE:39 [29;48]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj OR:0.61 [0.52;0.71]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Alpha Delta Omicron Other	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:39 [29;48]
Florea, A. (Sep, 2022)	United States (AMR)	Comparative Cohort	4,851	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Mod	Versus other COVID-19 vaccine exposure; Active or previous SARS-COV-2 infection	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:89 [86.2;91.2]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection; Non-previous SARS-CoV-2 infection	Mod	Versus other COVID-19 vaccine exposure; Active or previous SARS-COV-2 infection	Global	Nonspecified	7	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:63 [55.3;69.3]
Villar, J. (Jan, 2023)	NigeriaMexico, Japan, Italy, Israel, Indonesia, France, Egypt;Arab Rep., Brazil, Argentina (EUR WPR AMR AFR SEAR)	Comparative Cohort	2,886	General pregnant population vaccinated	AZD	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:56 [27;74]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:35 [0;64]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:48 [22;65]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:76 [47;89]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:35 [0;72]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:81 [47;93]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:61 [0;90]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:60 [2;83]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:49 [0;84]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:0 [0;70]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:8 [0;52]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:26 [0;46]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:20 [1;34]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:48 [32;61]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:32 [0;57]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:41 [22;55]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:54 [34;68]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:0 [0;40]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:0 [0;4]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:25 [0;52]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:4 [0;62]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:0 [0;8]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:31 [0;66]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:5 [0;18]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:9 [0;18]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:30 [19;39]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:0 [0;17]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:11 [0;21]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:32 [20;42]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:0 [0;13]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:2 [0;20]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:20 [0;38]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:28 [0;61]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:0 [0;20]
				General pregnant population vaccinated	Nonspecified	Unvaccinated	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:27 [0;51]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj RR:33 [0;67]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:74 [48;87]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:91 [65;98]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:29 [0;71]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:79 [49;91]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:94 [56;99]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:27 [0;89]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:56 [0;91]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:76 [0;96]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:66 [0;93]
Paixao, ES (Apr, 2022)	Brazil (AMR)	Case control	2,033	General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.32 [0.13;0.8]
				General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:67.74 [20;87]
				General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.14 [0.05;0.4]
				General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Severe COVID-19 - composite	Adj VE:85.39 [59.44;94.8]
				General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Symptomatic COVID-19	Adj OR:0.94 [0.76;1.18]
				General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:5.02 [-18.22;23.69]
				General pregnant population vaccinated	CRV	Unvaccinated	Non-specified	Delta Other	14	Nonspecified	Mother		Symptomatic COVID-19	Adj VE:40.97 [27.07;52.22]
Morgan, JA (Oct, 2021)	United States (AMR)	Comparative Cohort	1,536	General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Delta	15	60	Mother		Severe COVID-19 - composite	Adj OR:0.11 [0.01;0.53]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Non-specified	Delta	15	60	Mother		Virologically confirmed SARS-CoV-2 infection	Adj OR:0.31 [0.18;0.51]
Schrag, S.J. (Sep, 2022)	United States (AMR)	Case control	1,442	General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	14	365	Mother		Severe COVID-19 - composite	Adj VE:98 [96;99]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	14	149	Mother		Severe COVID-19 - composite	Adj VE:99 [96;100]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	14	365	Mother		Symptomatic COVID-19	Adj VE:83 [68;91]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	14	149	Mother		Symptomatic COVID-19	Adj VE:84 [69;92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	150	365	Mother		Severe COVID-19 - composite	Adj VE:96 [86;99]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	150	365	Mother		Symptomatic COVID-19	Adj VE:75 [5;93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	7	365	Mother		Severe COVID-19 - composite	Adj VE:97 [79;100]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	7	119	Mother		Severe COVID-19 - composite	Adj VE:97 [79;100]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	7	365	Mother		Symptomatic COVID-19	Adj VE:81 [33;95]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	7	119	Mother		Symptomatic COVID-19	Adj VE:81 [30;95]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	120	365	Mother		Severe COVID-19 - composite	Adj VE:-53 [-1254;83]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	120	365	Mother		Symptomatic COVID-19	Adj VE:-124 [-414;2]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	14	365	Mother		Severe COVID-19 - composite	Adj VE:77 [28;93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	14	149	Mother		Severe COVID-19 - composite	Adj VE:86 [41;97]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	14	365	Mother		Symptomatic COVID-19	Adj VE:16 [-22;42]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	14	149	Mother		Symptomatic COVID-19	Adj VE:3 [-49;37]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	150	365	Mother		Severe COVID-19 - composite	Adj VE:64 [-102;93]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	150	365	Mother		Symptomatic COVID-19	Adj VE:42 [-16;72]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	7	365	Mother		Severe COVID-19 - composite	Adj VE:76 [27;92]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	7	119	Mother		Severe COVID-19 - composite	Adj VE:86 [28;97]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	7	365	Mother		Symptomatic COVID-19	Adj VE:65 [41;79]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	7	119	Mother		Symptomatic COVID-19	Adj VE:79 [59;89]
Serra, F.E. (Oct, 2022)	Brazil (AMR)	Comparative Cohort	1,243	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Delta	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:1.11 [0.36;3.42]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Delta	Nonspecified	Nonspecified	Mother		COVID-19 related death	OR:0.75 [0.02;6.07]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Delta	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:1.24 [0.6;2.51]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:2.88 [1.34;6.21]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		COVID-19 related death	OR:3.38 [0.93;11.93]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Omicron	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:1.91 [1.13;3.17]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Other	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:1.54 [0.76;3.12]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Other	Nonspecified	Nonspecified	Mother		COVID-19 related death	OR:2.58 [1.03;6.06]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection	Nonspecified	Active or previous SARS-COV-2 infection; Vaccinated postpartum women	Non-specified	Other	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:1.78 [1;3.13]
Cardemil, C (Mar, 2024)	United States (AMR)	Comparative Cohort	475	General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	RRR (%):42 [-14;71]
				General pregnant population vaccinated	Mod Pfz	Versus other COVID-19 vaccine exposure	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Virologically confirmed SARS-CoV-2 infection	Adj RRR (%):56 [8;79]
Butt A.A. (Dec, 2021)	Qatar (EMR)	Comparative Cohort Case control	407	General pregnant population vaccinated	Mod	Unvaccinated	1st Tr; 2nd Tr	Alpha Beta	14	50	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:0 [0;1]
				General pregnant population vaccinated	Mod	Unvaccinated	1st Tr; 2nd Tr	Alpha Beta	14	50	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:100 [0;100]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr; 2nd Tr	Alpha Beta	14	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:46.3 [0;78.8]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr; 2nd Tr	Alpha Beta	14	50	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:87.6 [44.1;97.2]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr; 2nd Tr	Alpha Beta	14	50	Mother		Virologically confirmed SARS-CoV-2 infection	Adj HR:0.12 [0.03;0.56]
				General pregnant population vaccinated	Pfz	Unvaccinated	1st Tr; 2nd Tr	Alpha Beta	14	50	Mother		Virologically confirmed SARS-CoV-2 infection	Adj VE:87.7 [43.5;97.3]
Halasa, N.B. (Jun, 2022)	United States (AMR)	Case control	234	General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	320	Infant	6.00	Severe COVID-19 - composite	Adj VE:88 [68;96]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr; 2nd Tr	Delta	14	460	Infant	6.00	Severe COVID-19 - composite	Adj VE:68 [19;87]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta	14	460	Infant	6.00	Severe COVID-19 - composite	Adj VE:80 [60;90]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Delta Omicron	14	460	Infant	6.00	Severe COVID-19 - composite	Adj VE:47 [25;62]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr; 2nd Tr	Delta Omicron	14	460	Infant	6.00	Severe COVID-19 - composite	Adj VE:38 [3;60]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Delta Omicron	14	320	Infant	6.00	Severe COVID-19 - composite	Adj VE:69 [50;80]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	2nd Tr; 3rd Tr	Omicron	14	320	Infant	6.00	Severe COVID-19 - composite	Adj VE:57 [25;75]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	1st Tr; 2nd Tr	Omicron	14	460	Infant	6.00	Severe COVID-19 - composite	Adj VE:25 [-26;56]
				General pregnant population vaccinated	Mod Pfz	Unvaccinated	Global	Omicron	14	460	Infant	6.00	Severe COVID-19 - composite	Adj VE:38 [8;58]
Bleicher, I (Sep, 2021)	Israel (EUR)	Comparative Cohort	202	General pregnant population vaccinated	Pfz	Unvaccinated	Global	Nonspecified	Nonspecified	Nonspecified	Mother		Virologically confirmed SARS-CoV-2 infection	OR:4.5 [1.19;17.6]
Danino, D. (Oct, 2022)	Israel (EUR)	Case control	202	General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	360	Infant	2.00	Severe COVID-19 - composite	VE:63.8 [31.9;80.8]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	360	Infant	6.00	COVID-19 ICU admission with mechanical ventilation requirement	VE:82.7 [0;97.9]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	360	Infant	6.00	Severe COVID-19 - composite	Adj VE:61.6 [31.9;78.4]
				General pregnant population vaccinated	Pfz	Unvaccinated	2nd Tr; 3rd Tr	Delta	14	360	Infant	6.00	Severe COVID-19 - composite	VE:46.1 [0;83.4]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Infant	2.00	Severe COVID-19 - composite	VE:42.7 [0;71.9]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Infant	6.00	COVID-19 ICU admission with mechanical ventilation requirement	VE:7.7 [0;78]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Infant	6.00	Severe COVID-19 - composite	Adj VE:41.7 [0;68.6]
				General pregnant population vaccinated	Pfz	Unvaccinated	Non-specified	Delta	Nonspecified	Nonspecified	Infant	6.00	Severe COVID-19 - composite	VE:43.3 [0;82.6]
de Freitas Paganoti, C (May, 2022)	Brazil (AMR)	Comparative Cohort	200	Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	OR:0.22 [0.11;0.43]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 ICU admission with mechanical ventilation requirement	Adj OR:0.19 [0.09;0.41]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 related death	OR:0.188 [0.083;0.428]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Nonspecified	Nonspecified	Nonspecified	Mother		COVID-19 related death	Adj OR:0.207 [0.083;0.515]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	OR:0.52 [0.36;0.73]
				Previous SARS-CoV-2 infection	Nonspecified	Unvaccinated; Active or previous SARS-COV-2 infection	Non-specified	Nonspecified	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.54 [0.34;0.85]
Simeone, R (Sep, 2023)	United States (AMR)	Case control	176	General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	3.00	Severe COVID-19 - composite	Adj VE:54 [32;68]
				General pregnant population vaccinated	Mod Pfz J&J	Unvaccinated	Global	Omicron	Nonspecified	Nonspecified	Infant	6.00	Severe COVID-19 - composite	Adj VE:35 [15;51]
(-)	United Kingdom, Spain, South Africa, Brazil, United States (EUR AMR AFR)	Controlled clinical trial	173	General pregnant population vaccinated; Non-previous SARS-CoV-2 infection	Pfz	Placebo; Non-previous SARS-CoV-2 infection	3rd Tr	Nonspecified	Nonspecified	Nonspecified	Mother	1.00	Asymptomatic SAR-CoV-2 infection	VE:40.9 [NA;NA]
				General pregnant population vaccinated; Previous SARS-CoV-2 infection; Non-previous SARS-CoV-2 infection	Pfz	Placebo; Non-previous SARS-CoV-2 infection; Active or previous SARS-COV-2 infection	3rd Tr	Nonspecified	7	Nonspecified	Mother	0.99	Virologically confirmed SARS-CoV-2 infection	VE:35.1 [NA;NA]
Eid, J. (Jul, 2022)	United States (AMR)	Comparative Cohort	125	Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Delta	28	168	Mother		Symptomatic COVID-19	Adj OR:0.96 [0.3;3.41]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Delta Omicron Other	28	168	Mother		Severe COVID-19 - composite	Adj OR:0.14 [0.22;0.47]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Delta Omicron Other	28	168	Mother		Symptomatic COVID-19	Adj OR:1.2 [0.73;2.01]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Omicron	28	168	Mother		Severe COVID-19 - composite	Adj OR:0.14 [0.01;1.05]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Omicron	28	168	Mother		Symptomatic COVID-19	Adj OR:1.6 [0.67;3.91]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Other	28	168	Mother		Symptomatic COVID-19	Adj OR:1 [0.4;2.56]
				Previous SARS-CoV-2 infection	Mod Pfz J&J	Unvaccinated; Active or previous SARS-COV-2 infection	Global	Other	Nonspecified	Nonspecified	Mother		Severe COVID-19 - composite	Adj OR:0.33 [0.02;1.78]
Kammoun, M (Dec, 2023)	Tunisia (EMR)	Comparative Cohort	59	General pregnant population vaccinated; Previous SARS-CoV-2 infection	Pfz	Versus other COVID-19 vaccine exposure; Active or previous SARS-COV-2 infection	Global	Omicron	Nonspecified	Nonspecified	Mother	0.00	Asymptomatic SAR-CoV-2 infection	OR:5.5 [1.5;19.8]
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Immunogenicity

Pregnant people

Table 10: Study characteristics and main results from studies that assessed immunogenicity outcomes related to COVID-19 Vaccines in pregnant persons

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Comparator	Population for comparator	Vaccine product (Dose)b	Trimester of vaccine exposurec	Outcome	Tissue	Experimental group primary result	Units experimental group	Control group primary result	Units control group	SARS-CoV-2 Variant	Ratio
Bookstein Peretz, S. (Aug, 2021)	Israel	Case control	390	Non-pregnant	96	Pfz	Global	Spike (S) antibody	Blood	Mean: 27.03 (10.72)	signal-to-cut-off ratio	Mean: 34.35 (10.25)	signal-to-cut-off ratio	Nonspecified	0.79
Murphy, E (Aug, 2023)	United States	Comparative Cohort	2,491			Mod Pfz J&J	Global	Spike (S) antibody	Blood	Median: 4	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod Pfz J&J	Global	Spike (S) antibody	Blood	Median: 5.1	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod Pfz J&J	Global	Spike (S) antibody	Blood	Median: 7.4	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod Pfz J&J	Global	Spike (S) antibody	Blood	Median: 7.1	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod Pfz J&J	Global	Spike (S) antibody	Blood	Median: 7.1	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod Pfz J&J	Global	Spike (S) antibody	Blood	Median: 8.3	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Median: 4.5	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Median: 5.7	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Median: 7.9	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Median: 3.9	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Median: 5	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Median: 7.2	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Median: 7	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Median: 7.5	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Median: 8.4	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Median: 7.1	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Median: 7	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Median: 8.3	Maternal Anti-S IgG (log₂)		Maternal Anti-S IgG (log₂)	Nonspecified
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.7	Maternal neutralizing activity against B.1 spike variant (log₁₀)		Maternal neutralizing activity against B.1 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.9	Maternal neutralizing activity against B.1 spike variant (log₁₀)		Maternal neutralizing activity against B.1 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 4	Maternal neutralizing activity against B.1 spike variant (log₁₀)		Maternal neutralizing activity against B.1 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.8	Maternal neutralizing activity against BA.1 spike variant (log₁₀)		Maternal neutralizing activity against BA.1 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.6	Maternal neutralizing activity against BA.1 spike variant (log₁₀)		Maternal neutralizing activity against BA.1 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.9	Maternal neutralizing activity against BA.1 spike variant (log₁₀)		Maternal neutralizing activity against BA.1 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.4	Maternal neutralizing activity against BA.5 spike variant (log₁₀)		Maternal neutralizing activity against BA.5 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.3	Maternal neutralizing activity against BA.5 spike variant (log₁₀)		Maternal neutralizing activity against BA.5 spike variant (log₁₀)	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.4	Maternal neutralizing activity against BA.5 spike variant (log₁₀)		Maternal neutralizing activity against BA.5 spike variant (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.9	Maternal neutralizing activity agains B.1 (log₁₀)		Maternal neutralizing activity agains B.1 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 4.1	Maternal neutralizing activity agains B.1 (log₁₀)		Maternal neutralizing activity agains B.1 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.8	Maternal neutralizing activity agains B.1 (log₁₀)		Maternal neutralizing activity agains B.1 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 4	Maternal neutralizing activity agains B.1 (log₁₀)		Maternal neutralizing activity agains B.1 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.5	Maternal neutralizing activity agains BA.1 (log₁₀)		Maternal neutralizing activity agains BA.1 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.8	Maternal neutralizing activity agains BA.1 (log₁₀)		Maternal neutralizing activity agains BA.1 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.7	Maternal neutralizing activity agains BA.1 (log₁₀)		Maternal neutralizing activity agains BA.1 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.9	Maternal neutralizing activity agains BA.1 (log₁₀)		Maternal neutralizing activity agains BA.1 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.1	Maternal neutralizing activity agains BA.5 (log₁₀)		Maternal neutralizing activity agains BA.5 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.3	Maternal neutralizing activity agains BA.5 (log₁₀)		Maternal neutralizing activity agains BA.5 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.3	Maternal neutralizing activity agains BA.5 (log₁₀)		Maternal neutralizing activity agains BA.5 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.4	Maternal neutralizing activity agains BA.5 (log₁₀)		Maternal neutralizing activity agains BA.5 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.9	Maternal neutralizing activity agains B.1 (log₁₀)		Maternal neutralizing activity agains B.1 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.7	Maternal neutralizing activity agains B.1 (log₁₀)		Maternal neutralizing activity agains B.1 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.8	Maternal neutralizing activity agains B.A1 (log₁₀)		Maternal neutralizing activity agains B.A1 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.8	Maternal neutralizing activity agains B.A1 (log₁₀)		Maternal neutralizing activity agains B.A1 (log₁₀)	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.5	Maternal neutralizing activity agains BA.5 (log₁₀)		Maternal neutralizing activity agains BA.5 (log₁₀)	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 3.4	Maternal neutralizing activity agains BA.5 (log₁₀)		Maternal neutralizing activity agains BA.5 (log₁₀)	Omicron Other
Yang, YJ (Dec, 2021)	United States	Comparative Cohort	1,321			Pfz	1st Tr	Spike (S) antibody	Blood	Median: 3.9 [2.4;5.4]	Relative index value		Relative index value	Nonspecified
						Pfz	2nd Tr	Spike (S) antibody	Blood	Median: 4.8 [3.1;6.5]	Relative index value		Relative index value	Nonspecified
						Pfz	3rd Tr	Spike (S) antibody	Blood	Median: 6.4 [4.9;7.9]	Relative index value		Relative index value	Nonspecified
						Mod	1st Tr	Spike (S) antibody	Blood	Median: 4.8 [3.3;6.3]	Relative index value		Relative index value	Nonspecified
						Mod	2nd Tr	Spike (S) antibody	Blood	Median: 5.7 [4.2;7.2]	Relative index value		Relative index value	Nonspecified
						Mod	3rd Tr	Spike (S) antibody	Blood	Median: 7.1 [5.8;8.4]	Relative index value		Relative index value	Nonspecified
						J&J	1st Tr	Spike (S) antibody	Blood	Median: 3.6 [1.7;5.5]	Relative index value		Relative index value	Nonspecified
						J&J	2nd Tr	Spike (S) antibody	Blood	Median: 3 [1.2;4.8]	Relative index value		Relative index value	Nonspecified
						J&J	3rd Tr	Spike (S) antibody	Blood	Median: 2.5 [0;6.4]	Relative index value		Relative index value	Nonspecified
						Mod Pfz J&J	Global	Spike (S) antibody	Cord blood					Nonspecified
				Previous infection	170	Mod Pfz J&J	Global	Spike (S) antibody	Cord blood					Nonspecified
Rottenstreich, A. (Feb, 2022)	Israel	Comparative Cohort	432	Versus other COVID-19 vaccine exposure	30	Pfz	1st Tr	Spike (S) antibody	Blood	Median: 76	AU/ml	Median: 1665	AU/ml	Nonspecified	0.05
				Versus other COVID-19 vaccine exposure	30	Pfz	1st Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 478	AU/ml	Median: 20946	AU/ml	Nonspecified	0.02
						Pfz	2nd Tr	Spike (S) antibody	Blood	Median: 126	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1263	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	Spike (S) antibody	Blood	Median: 240	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 5855	AU/ml		AU/ml	Nonspecified
						Pfz	1st Tr	Neutralizing SARS-CoV-2 antibody level	Blood	Median: 16	median NT50		median NT50	Nonspecified
						Pfz	2nd Tr	Neutralizing SARS-CoV-2 antibody level	Blood	Median: 80	median NT50		median NT50	Nonspecified
						Pfz	3rd Tr	Neutralizing SARS-CoV-2 antibody level	Blood	Median: 295	median NT50:		median NT50:	Nonspecified
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection; late 3rd trimester (32-36 weeks)		Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 9516	AU/ml	Median: 6811	AU/ml	Nonspecified	1.40
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection; late 3rd trimester (32-36 weeks)		Pfz	3rd Tr	Transplacental transfer for anti-RBD-specific IgG	Blood	Median: 2.4	placental transfer ratio	Median: 0.8	placental transfer ratio	Nonspecified	3.00
Kugelman, N. (May, 2022)	Israel	Comparative Cohort	242	Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	121	Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 4485.3 [2569;9702.7]	AU/ml	Median: 1122 [2569;9702.7]	AU/ml	Nonspecified	4.00
Munoz, F. (Jun, 2023)	United States	Comparative Cohort	240			Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 2201	BAU/mL		BAU/mL	Nonspecified
						Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 236	BAU/mL		BAU/mL	Nonspecified
						Mod	Global	Spike (S) antibody	Blood	Geometric Mean: 479	BAU/mL		BAU/mL	Nonspecified
				Versus other COVID-19 vaccine exposure	73	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Adj PR:1.1 [1.03;1.18]		Adj PR:1.1 [1.03;1.18]		Other
				Versus other COVID-19 vaccine exposure	73	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Adj PR:1.46 [1.28;1.68]		Adj PR:1.46 [1.28;1.68]		Delta
				Versus other COVID-19 vaccine exposure	73	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Adj PR:3.16 [2.13;4.71]		Adj PR:3.16 [2.13;4.71]		Omicron
				Versus other COVID-19 vaccine exposure	73	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Adj PR:1.05 [1.01;1.09]		Adj PR:1.05 [1.01;1.09]		Other
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 630.3				Other
						Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 62.2				Other
						Mod	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 192.5	Live virus nAb titers to D614G were measured post-vaccination in pregnant participants (GMT ID50)		Live virus nAb titers to D614G were measured post-vaccination in pregnant participants (GMT ID50)	Other
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 446.4				Nonspecified
						Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 49.9				Nonspecified
						Mod	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 179.5				Nonspecified
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 60.2				Omicron Other
						Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 12.7				Omicron Other
						Mod	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 14.7				Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Geometric Mean: 108				Nonspecified
						Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Geometric Mean: 708				Nonspecified
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Geometric Mean: 154				Nonspecified
						Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Geometric Mean: 513				Nonspecified
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Geometric Mean: 78				Nonspecified
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Geometric Mean: 122				Nonspecified
Cahen-Peretz, A. (Jan, 2023)	Israel	Comparative Cohort	213	Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	127	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 5598.4 [2987.7;1159.6]	AU/mL	Median: 768.4 [2987.7;1159.6]	AU/mL	Overall	7.29
Flannery, D. (Nov, 2022)	United States	Comparative Cohort	177	Unvaccinated; Active or previous SARS-COV-2 infection	408	Mod Pfz J&J	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 33.88	AU/ml	Geometric Mean: 2.8	AU/ml	Nonspecified	12.10
				Unvaccinated; Active or previous SARS-COV-2 infection; Asymptomatic	265	Mod Pfz J&J	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 33.88	AU/ml	Geometric Mean: 2.41	AU/ml	Nonspecified	14.06
				Unvaccinated; Active or previous SARS-COV-2 infection; Symptomatic	143	Mod Pfz J&J	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 33.88	AU/ml	Geometric Mean: 3.71	AU/ml	Nonspecified	9.13
				Unvaccinated; Active or previous SARS-COV-2 infection	408	Pfz	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 25.45	AU/ml	Geometric Mean: 2.8	AU/ml	Nonspecified	9.09
				Unvaccinated; Active or previous SARS-COV-2 infection	408	Mod	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 53.74	AU/ml	Geometric Mean: 2.8	AU/ml	Nonspecified	19.19
				Unvaccinated; Active or previous SARS-COV-2 infection	408	J&J	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 7.04	AU/ml	Geometric Mean: 2.8	AU/ml	Nonspecified	2.51
				Unvaccinated; Active or previous SARS-COV-2 infection	408	Nonspecified	Global	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 46.72	AU/ml	Geometric Mean: 2.8	AU/ml	Nonspecified	16.69
Blakeway, H. (Nov, 2022)	United Kingdom	Comparative Cohort	175	Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	11	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 0.7	AU/ml	Geometric Mean: 12	AU/ml	Nonspecified	0.06
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	3	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 0.7	AU/ml	Geometric Mean: 1.07	AU/ml	Nonspecified	0.65
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	50	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 160.61	AU/ml	Geometric Mean: 102.1	AU/ml	Nonspecified	1.57
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	29	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 160.61	AU/ml	Geometric Mean: 32.26	AU/ml	Nonspecified	4.98
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	24	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 625.76	AU/ml	Geometric Mean: 2617.6	AU/ml	Nonspecified	0.24
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	9	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 625.76	AU/ml	Geometric Mean: 132.7	AU/ml	Nonspecified	4.72
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	20	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 5198.92	AU/ml	Geometric Mean: 17306.87	AU/ml	Nonspecified	0.30
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	7	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 5198.92	AU/ml	Geometric Mean: 1662.97	AU/ml	Nonspecified	3.13
				Versus other COVID-19 vaccine exposure; Non-pregnant	1	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 618.6	AU/ml	Geometric Mean: 161	AU/ml	Nonspecified	3.84
				Versus other COVID-19 vaccine exposure; Non-pregnant	1	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 618.6	AU/ml	Geometric Mean: 2500	AU/ml	Nonspecified	0.25
				Versus other COVID-19 vaccine exposure; Non-pregnant	13	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 11683.86	AU/ml	Geometric Mean: 29217.12	AU/ml	Nonspecified	0.40
				Versus other COVID-19 vaccine exposure; Non-pregnant	8	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 11683.86	AU/ml	Geometric Mean: 17992.12	AU/ml	Nonspecified	0.65
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	4	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 11324.36	AU/ml	Geometric Mean: 9902.47	AU/ml	Nonspecified	1.14
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	2	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 11324.36	AU/ml	Geometric Mean: 21506.98	AU/ml	Nonspecified	0.53
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	1	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 14395.44	AU/ml	Geometric Mean: 39014	AU/ml	Nonspecified	0.37
				Versus other COVID-19 vaccine exposure; Types of population; Non-pregnant	2	Mod Pfz	Global	Spike (S) antibody	Blood	Geometric Mean: 14395.44	AU/ml (negative)	Geometric Mean: 16435.09	AU/ml (negative)	Nonspecified	0.88
Nevo, L. (Sep, 2022)	Israel	Comparative Cohort	174	Unvaccinated; Active or previous SARS-COV-2 infection	54	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 2608 [1223;8094.3]	AU/ml	Median: 148.3 [1223;8094.3]	AU/ml	Nonspecified	17.59
				Unvaccinated; Active or previous SARS-COV-2 infection	54	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 797.7 [423.7;1662.9]	AU/ml	Median: 148.3 [423.7;1662.9]	AU/ml	Nonspecified	5.38
Citu, IM (Feb, 2022)	Romania	Comparative Cohort	173	Seropisitive cases	54	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 2433 [1752;3094]	U/mL	Median: 15360 [1752;3094]	U/mL	Alpha Delta	0.16
				Seropisitive cases	54	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1697 [1393;2115]	U/mL	Median: 14571 [1393;2115]	U/mL	Alpha Delta	0.12
				Seropisitive cases	54	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1314 [1095;1762]	U/mL	Median: 12870 [1095;1762]	U/mL	Alpha Delta	0.10
				Seropisitive cases	54	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1083 [896;1468]	U/mL	Median: 10759 [896;1468]	U/mL	Alpha Delta	0.10
				Non-pregnant	173	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 2433 [1752;3094]	U/mL	Median: 2461 [1752;3094]	U/mL	Alpha Delta	0.99
				Non-pregnant	173	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1697 [1393;2115]	U/mL	Median: 1705 [1393;2115]	U/mL	Alpha Delta	1.00
				Non-pregnant	173	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1314 [1095;1762]	U/mL	Median: 1377 [1095;1762]	U/mL	Alpha Delta	0.95
				Non-pregnant	173	Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 1083 [896;1468]	U/mL	Median: 1114 [896;1468]	U/mL	Alpha Delta	0.97
Toussia-Cohen, S. (Aug, 2022)	Israel	Comparative Cohort	162	Versus other COVID-19 vaccine exposure	78	Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 2177.93 (1525.89)	BAU/mL	Mean: 1333.75 (917.35)	BAU/mL	Nonspecified	1.63
						Pfz	2nd Tr	SARS-CoV-2 IgG Before third dose	Blood	Mean: 108.01 (74.69)	BAU/mL		BAU/mL	Nonspecified
Lubrano, C. (Apr, 2023)	Italy	Comparative Cohort	127	Unvaccinated	45	Mod Pfz AZD	Non-specified	Spike (S) antibody	Blood					Nonspecified
				Unvaccinated	12	Mod Pfz AZD	Non-specified	Th1 (IFNy-expressing T-cells)						Nonspecified
Mayo, R.P. (Nov, 2021)	Israel	Comparative Cohort	125	Unvaccinated; 212		Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Other					Alpha Other
				Unvaccinated; SARS-CoV-2 during pregnancy	212	Pfz	2nd Tr; 3rd Tr	IgM	Other					Alpha Other
				Unvaccinated; 212		Pfz	2nd Tr; 3rd Tr	IgM	Cord blood					Alpha Other
				Unvaccinated; SARS-CoV-2 during pregnancy	212	Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Other					Alpha Other
				Unvaccinated; SARS-CoV-2 during pregnancy	212	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood					Alpha Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	212	Pfz	2nd Tr; 3rd Tr	Maternal IgG - S1	Other					Alpha Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	212	Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Other					Alpha Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	212	Pfz	2nd Tr; 3rd Tr	Maternal IgG - S2	Other					Alpha Other
Anwar AD (Jan, 2023)	Indonesia	Comparative Cohort	103	Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	28	Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 18649.11 (14091.17) Median: 19702.6 [138.4;40000]	AU/mL	Mean: 2966.86 (7529.31) Median: 1040.25 [138.4;40000]	AU/mL	Delta Omicron	6.29
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	19	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 15530.65 (1878.87) Median: 16680.5 [237.9;40000]	AU/mL	Mean: 1380.27 (2506.06) Median: 966.1 [237.9;40000]	AU/mL	Delta Omicron	11.25
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	47	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 6 (13355.43) Median: 18434.9 [138.4;40000]	AU/mL	Mean: 2325.47 (6029.25) Median: 977.4 [138.4;40000]	AU/mL	Delta Omicron	0.00
Toussia-Cohen, S. (Nov, 2022)	Israel	Comparative Cohort	103			Nonspecified	Global	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 113.5	Maternal serum IgG (BAU/mL)		Maternal serum IgG (BAU/mL)	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 333.5	Maternal serum IgG (BAU/mL)		Maternal serum IgG (BAU/mL)	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 741.6	Maternal serum IgG (BAU/mL)		Maternal serum IgG (BAU/mL)	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 57.99	Maternal serum IgG (BAU/mL)		Maternal serum IgG (BAU/mL)	Nonspecified
Otero, S (Jan, 2023)	United States	Comparative Cohort	99	Unvaccinated; COVID 19 during pregnancy	159	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 16.54 [8.58;28.53]	AU/ml	Median: 1.67 [8.58;28.53]	AU/ml	Nonspecified	9.90
				Unvaccinated; Active or previous SARS-COV-2 infection	252	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
				Unvaccinated; COVID 19 during pregnancy	252	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 20.4	AU/ml	Median: 2.67	AU/ml	Nonspecified	7.64
				Unvaccinated; COVID 19 during pregnancy	252	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 5.17	AU/ml	Median: 1.21	AU/ml	Nonspecified	4.27
Avni Biron, I. (Oct, 2022)	Israel	Comparative Cohort	97	Versus other COVID-19 vaccine exposure; Pregnant without IBD	61	Pfz	2nd Tr	Spike (S) antibody	Blood	Geometric Mean: 2442	AU/mL	Geometric Mean: 977	AU/mL	Nonspecified	2.50
				Versus other COVID-19 vaccine exposure; Pregnant without IBD	61	Pfz	2nd Tr	Spike (S) antibody	Blood					Nonspecified
Beharier, O. (May, 2021)	Israel	Comparative Cohort	92	Unvaccinated	66	Pfz	Non-specified	RBD Antigen-specific ELISA (IgG)	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	65	Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	65	Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
				Unvaccinated; Active or previous SARS-COV-2 infection	127	Pfz	Non-specified	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 16474.9		Mean: 6820.6		Nonspecified	2.42
				Unvaccinated; Active or previous SARS-COV-2 infection	127	Pfz	Non-specified	IgG - S1	Blood	Mean: 12718.9		Mean: 3954.7		Nonspecified	3.22
Popescu, D. (May, 2022)	Romania	Comparative Cohort	91	Versus other COVID-19 vaccine exposure; COVID-19 disease during pregnancy before vaccine	26	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 2463.92 (3267.3) [1654.32;3273.52]	U/ml	Mean: 11610.44 (5373.4) [9440.08;13780.8]	U/ml	Nonspecified	0.21
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 5077.21 (5733.64) [3883.12;6271.3]	U/ml		U/ml	Nonspecified
				Versus other COVID-19 vaccine exposure; COVID-19 disease during pregnancy before vaccine	26	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Breast milk	Mean: 30.98 (45.38) [19.64;42.31]	U/ml	Mean: 114.89 (53.27) [93.37;136.4]	U/ml	Nonspecified	0.27
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Breast milk	Mean: 55.22 (60.97) [42.45;67.99]	U/ml		U/ml	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood					Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Breast milk					Nonspecified
Dawood, F (Apr, 2023)	United States	Comparative Cohort	85	Non-pregnant	23	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 97		Geometric Mean: 88		Nonspecified	1.10
				Non-pregnant	23	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 1722		Geometric Mean: 4419		Nonspecified	0.39
				Active or previous SARS-COV-2 infection	78	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 270		Geometric Mean: 131		Other	2.06
				Active or previous SARS-COV-2 infection	78	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 108		Geometric Mean: 48		Alpha	2.25
				Active or previous SARS-COV-2 infection	78	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 79		Geometric Mean: 21		Other	3.76
				Active or previous SARS-COV-2 infection	78	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 84		Geometric Mean: 65		Delta	1.29
				Active or previous SARS-COV-2 infection	78	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 6		Geometric Mean: 6		Omicron Other	1.00
				Active or previous SARS-COV-2 infection	78	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 9		Geometric Mean: 7		Omicron Other	1.29
						Mod Pfz	1st Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 71 [13;380]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 38 [17;84]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 28 [10;80]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	1st Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 1169 [322;4247]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 994 [535;1846]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 1348 [568;3203]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	1st Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 131 [38;448]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 183 [101;334]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 924 [413;2068]	AU/mL		AU/mL	Nonspecified
Atyeo, C. (Oct, 2021)	United States	Comparative Cohort	84	Versus other COVID-19 vaccine exposure; Non-pregnant; Lactating	28	Mod Pfz	Global	FcR binding	Blood					Nonspecified
Gray, K.J. (Sep, 2021)	United States	Comparative Cohort	84			Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood					Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Cord blood					Nonspecified
						Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Breast milk					Nonspecified
				Non-pregnant; Lactating	47	Mod Pfz	Global	Spike (S) antibody	Blood					Nonspecified
Shanes, E.D. (Aug, 2021)	United States	Comparative Cohort	84	Unvaccinated; Non-previous SARS-CoV-2 infection	116	Nonspecified	Non-specified	Anti-SARS-CoV-2 signal/cutoff ratio		Mean: 22.8 (14.5)	signal/cutoff ratio	Mean: 0.04 (0.05)	signal/cutoff ratio	Nonspecified	570.00
				Unvaccinated; Non-previous SARS-CoV-2 infection	116	Nonspecified	Non-specified	Anti-SARS-CoV-2 IgG over cutoff						Nonspecified
Sunder, A. (Oct, 2022)	Bahrain	Comparative Cohort	79	Versus other COVID-19 vaccine exposure	42	SIN	2nd Tr; 3rd Tr	Spike (S) antibody	Blood	Median: 50.3 [11;311]	U/mL	Median: 1153.5 [11;311]	U/mL	Nonspecified	0.04
Shook, L (Feb, 2022)	United States	Comparative Cohort	77	Unvaccinated; Active or previous SARS-COV-2 infection	12	Mod Pfz	2nd Tr; 3rd Tr	Spike (S) antibody	Blood	Mean: 2.03 (0.47)	OD 450-570	Mean: 0.65 (0.76)	OD 450-570	Nonspecified	3.12
Nir,O (Jan, 2022)	Israel	Comparative Cohort	64	Active or previous SARS-COV-2 infection	11	Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 26.1 [22;39.7]		Median: 2.6 [22;39.7]		Nonspecified	10.04
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Breast milk	Median: 4.9 [3.8;6]				Nonspecified
Kigel, A (Jul, 2023)	Israel	Comparative Cohort	62			Pfz	Non-specified	anti- Spike IgG	Other	Median: 1.098 [0.498;2.424]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	anti- Spike IgG	Other	Median: 0.267 [0.147;0.564]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	anti- Spike IgG	Other	Median: 0.204 [0.108;0.477]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	IgA responses (in breastmilk)	Other	Median: 46.19 [30.89;77.54]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	IgA responses (in breastmilk)	Other	Median: 12.15 [9.123;19.11]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	IgA responses (in breastmilk)	Other	Median: 10.15 [6.898;14.78]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	anti- Spike IgM	Other	Median: 0.144 [0.089;0.356]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	anti- Spike IgM	Other	Median: 0.042 [0.03;0.054]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	anti- Spike IgM	Other	Median: 0.026 [0.014;0.05]	mcg/mL		mcg/mL	Nonspecified
						Pfz	3rd Tr	anti- Spike IgG	Other	Median: 0.66 [0.538;1.167]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr	anti- Spike IgG	Other	Median: 0.188 [0.128;0.261]	mcg/mL		mcg/mL	Nonspecified
						Pfz	3rd Tr	anti- Spike IgG	Other	Median: 0.451	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr	anti- Spike IgG	Other	Median: 0.125 [0.094;0.208]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr	IgA responses (in breastmilk)	Other	Median: 13.8 [10.32;22.3]	mcg/mL		mcg/mL	Nonspecified
						Pfz	3rd Tr	IgA responses (in breastmilk)	Other	Median: 9.915 [6.199;11.82]	mcg/mL		mcg/mL	Nonspecified
						Pfz	2nd Tr	IgA responses (in breastmilk)	Other	Median: 13.06 [8.232;18.41]	mcg/mL		mcg/mL	Nonspecified
						Pfz	3rd Tr	IgA responses (in breastmilk)	Other	Median: 8.51 [5.125;12.6]	mcg/mL		mcg/mL	Nonspecified
Prabhu, M. (Nov, 2022)	United States	Comparative Cohort	53	Non-pregnant; Non-previous SARS-CoV-2 infection	7	Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 2	Anti-S Antibody levels (log 10 Endpoint dilution)	Mean: 2	Anti-S Antibody levels (log 10 Endpoint dilution)	Nonspecified	1.00
				Non-pregnant; Non-previous SARS-CoV-2 infection	12	Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 4.3	Anti-S Antibody levels (log 10 Endpoint dilution)	Mean: 4.5	Anti-S Antibody levels (log 10 Endpoint dilution)	Nonspecified	0.96
				Non-pregnant; Non-previous SARS-CoV-2 infection	16	Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 5.5	Anti-S Antibody levels (log 10 Endpoint dilution)	Mean: 5.7	Anti-S Antibody levels (log 10 Endpoint dilution)	Nonspecified	0.96
				Non-pregnant; Non-previous SARS-CoV-2 infection	7	Mod Pfz	Global	Anti-S Ig A	Blood	Mean: 2	Anti-S Antibody levels (log 10 Endpoint dilution)	Mean: 2	Anti-S Antibody levels (log 10 Endpoint dilution)	Nonspecified	1.00
				Non-pregnant; Non-previous SARS-CoV-2 infection	12	Mod Pfz	Global	Anti-S Ig A	Blood	Mean: 2.7	Anti-S Antibody levels (log 10 Endpoint dilution)	Mean: 3	Anti-S Antibody levels (log 10 Endpoint dilution)	Nonspecified	0.90
				Non-pregnant	16	Mod Pfz	Global	Anti-S Ig A	Blood	Mean: 3.4	Anti-S Antibody levels (log 10 Endpoint dilution)	Mean: 3.9	Anti-S Antibody levels (log 10 Endpoint dilution)	Nonspecified	0.87
Boelig R. (Mar, 2022)	United States	Comparative Cohort	49	Unvaccinated; Active or previous SARS-COV-2 infection	200	Nonspecified	Non-specified	Intracellular cytokines						Nonspecified
Gigase, F (Mar, 2024)	United States	Comparative Cohort	36	Unvaccinated	185	Mod Pfz J&J	Global	Th17						Nonspecified
Dude, C (Jan, 2023)	United States	Comparative Cohort	34	Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	Sars-CoV 2 antibody (IgA)	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	IgM anti SARS-CoV-2	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood					Nonspecified
Golan, N. (Dec, 2022)	Israel	Comparative Cohort	31			Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 198.7 [117.3;280]	AU/ml		AU/ml	Nonspecified
ATYEO, C (May, 2022)	United States	Comparative Cohort	31	Non-pregnant	20	Mod Pfz	3rd Tr	Spike (S) antibody	Blood	Mean: 170000	median fluorescence intensity (MFI)	Mean: 460000	median fluorescence intensity (MFI)	Other	0.37
				Non-pregnant	20	Mod Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 130000	median fluorescence intensity (MFI).	Mean: 350000	median fluorescence intensity (MFI).	Other	0.37
				lactating	12	Mod Pfz	3rd Tr	Spike (S) antibody	Blood	Mean: 170000	median fluorescence intensity (MFI).	Mean: 220000	median fluorescence intensity (MFI).	Other	0.77
				lactating	12	Mod Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 130000	median fluorescence intensity (MFI).	Mean: 210000	median fluorescence intensity (MFI).	Other	0.62
				Non-pregnant	20	Mod Pfz	3rd Tr	Spike (S) antibody	Blood	Mean: 120000	median fluorescence intensity (MFI)	Mean: 2e+05	median fluorescence intensity (MFI)	Omicron	0.60
				lactating	12	Mod Pfz	3rd Tr	Spike (S) antibody	Blood	Mean: 120000	median fluorescence intensity (MFI)	Mean: 150000	median fluorescence intensity (MFI)	Omicron	0.80
				same individuals 4 weeks after the booster dose	5	Mod Pfz	3rd Tr	Spike (S) antibody	Blood	Mean: 14000	median fluorescence intensity (MFI)	Mean: 110000	median fluorescence intensity (MFI)	Omicron	0.13
Matsui, Y. (May, 2022)	United States	Comparative Cohort	30	Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Mean: 123	Mean nAb titer at 50% inhibition (NT50)	Mean: 95	Mean nAb titer at 50% inhibition (NT50)	Other	1.29
Chen, W. (Oct, 2022)	Taiwan;China	Comparative Cohort	20			Mod	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 0 [0;12.87]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 143.27 [110.61;200.35]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 146.91 [120.19;173.63]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 127.99 [102.28;184.02]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 157.14 [127.55;267.39]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 0 [0;0]	ng/mL		ng/mL	Omicron
Juttukonda, L. J (Sep, 2022)	United States	Comparative Cohort	17	Unvaccinated; Non-previous SARS-CoV-2 infection	9	Mod Pfz	Non-specified	Intracellular cytokines		Mean: 21.3	decidual IL-6 level (pg/mg protein)	Mean: 27.5	decidual IL-6 level (pg/mg protein)	Nonspecified	0.77
				Active or previous SARS-COV-2 infection	8	Mod Pfz	Non-specified	Intracellular cytokines		Mean: 21.3	decidual IL-6 level (pg/mg protein)	Mean: 15.9	decidual IL-6 level (pg/mg protein)	Nonspecified	1.34
				Unvaccinated; Non-previous SARS-CoV-2 infection	9	Mod Pfz	Non-specified	Intracellular cytokines		Mean: 2	decidual IL-10 level (pg/mg protein)	Mean: 2.3	decidual IL-10 level (pg/mg protein)	Nonspecified	0.87
				Active or previous SARS-COV-2 infection	8	Mod Pfz	Non-specified	Intracellular cytokines		Mean: 2	decidual IL-10 level (pg/mg protein)	Mean: 2	decidual IL-10 level (pg/mg protein)	Nonspecified	1.00
				Unvaccinated; Non-previous SARS-CoV-2 infection	9	Mod Pfz	Non-specified	Intracellular cytokines		Mean: 43.7	decidual IP-10 level (pg/mg protein)	Mean: 74.6	decidual IP-10 level (pg/mg protein)	Nonspecified	0.59
				Active or previous SARS-COV-2 infection	8	Mod Pfz	Non-specified	Intracellular cytokines		Mean: 43.7	decidual IP-10 level (pg/mg protein)	Mean: 47.6	decidual IP-10 level (pg/mg protein)	Nonspecified	0.92
						Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Blood	Mean: 37746	AU/mL		AU/mL	Nonspecified
						Mod	Non-specified	Intracellular cytokines		Mean: 21.5	decidual IL-6 level (pg/mg protein)		decidual IL-6 level (pg/mg protein)	Nonspecified
						Pfz	Non-specified	Intracellular cytokines		Mean: 21.5	decidual IL-6 level (pg/mg protein)		decidual IL-6 level (pg/mg protein)	Nonspecified
						Mod	Non-specified	Intracellular cytokines		Mean: 2.3	decidual IL-10 level (pg/mg protein)		decidual IL-10 level (pg/mg protein)	Nonspecified
						Pfz	Non-specified	Intracellular cytokines		Mean: 1.8	decidual IL-10 level (pg/mg protein)		decidual IL-10 level (pg/mg protein)	Nonspecified
						Mod	Non-specified	Intracellular cytokines		Mean: 25.1	decidual IP-10 level (pg/mg protein)		decidual IP-10 level (pg/mg protein)	Nonspecified
						Pfz	Non-specified	Intracellular cytokines		Mean: 57.8	decidual IP-10 level (pg/mg protein)		decidual IP-10 level (pg/mg protein)	Nonspecified
Alhousseini A. (Jun, 2022)	United States	Comparative Cohort	16	Unvaccinated; Non-previous SARS-CoV-2 infection	23	Mod Pfz	Non-specified	SARS-CoV-2 Nucleocaspid IgG	Cord blood					Nonspecified
				Unvaccinated; Covid-19 during pregnancy	22	Mod Pfz	Non-specified	SARS-CoV-2 Nucleocaspid IgG	Cord blood					Nonspecified
				Unvaccinated; Covid-19 during pregnancy	22	Mod Pfz	Non-specified	IL-6 Levels		Mean: 7.11 (2.468)	pg/mL	Mean: 9 (3.34)	pg/mL	Nonspecified	0.79
				Unvaccinated; Covid-19 during pregnancy	22	Mod Pfz	Non-specified	CRP levels						Nonspecified
				Unvaccinated; Non-previous SARS-CoV-2 infection	23	Mod Pfz	Non-specified	IL-6 Levels		Mean: 7.11 (2.468)	pg/mL	Mean: 5.19 (0.759)	pg/mL	Nonspecified	1.37
				Unvaccinated; Non-previous SARS-CoV-2 infection	23	Mod Pfz	Non-specified	CRP levels						Nonspecified
Monroe, J (Oct, 2023)	United States	Comparative Cohort	12	Active or previous SARS-COV-2 infection	34	Pfz	2nd Tr; 3rd Tr	Spike (S) antibody	Blood					Nonspecified
(-)	United Kingdom, Spain, South Africa, Brazil, United States	Controlled clinical trial	173	Non-pregnant; Non-previous SARS-CoV-2 infection	107	Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 1109.2		Geometric Mean: 1663.7		Nonspecified	0.67
				Non-pregnant; Non-previous SARS-CoV-2 infection; Active or previous SARS-COV-2 infection	114	Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 2198.7		Geometric Mean: 1732		Nonspecified	1.27
				Placebo; Non-previous SARS-CoV-2 infection	35	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 7802		Geometric Mean: 1.8		Nonspecified	4,334.44
				Placebo; Non-previous SARS-CoV-2 infection	31	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 4281		Geometric Mean: 1.8		Nonspecified	2,378.33
				Placebo	29	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 2747.6		Geometric Mean: 1.7		Nonspecified	1,616.24
				Placebo; Non-previous SARS-CoV-2 infection	0	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 1639.4				Nonspecified
				Placebo; Non-previous SARS-CoV-2 infection	35	Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 1991.8		Geometric Mean: 45		Nonspecified	44.26
				Placebo; Non-previous SARS-CoV-2 infection	31	Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 1212.6		Geometric Mean: 43.5		Nonspecified	27.88
				Placebo; Non-previous SARS-CoV-2 infection	29	Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 695.7		Geometric Mean: 43.5		Nonspecified	15.99
				Placebo; Non-previous SARS-CoV-2 infection	0	Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 465.4				Nonspecified
Chayachinda, Ch (Aug, 2023)	Thailand	Controlled clinical trial	124			Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 107.14	BAU/mL		BAU/mL	Nonspecified
						AZDi	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 84.85	BAU/mL		BAU/mL	Nonspecified
						CRV	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 11.83	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 2072.84	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 1754.61	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 1609.68	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 258.22				Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 187.47				Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 166.63				Other
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 362.73	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 360.73	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 401.15	BAU/mL		BAU/mL	Nonspecified
						Pfz AZDi CRV	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 46.23	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 1806.36	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 372.93	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 201.97	BAU/mL		BAU/mL	Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 12.07	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 11.32	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 13.62	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 11.6	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 16.14	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 17.07	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 16.13	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 15.24	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 10.43	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 11.14	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 10.13	BAU/mL		BAU/mL	Omicron Other
						Pfz	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 10	BAU/mL		BAU/mL	Omicron Other
Abu Shqara, R (Jun, 2023)	Israel	Cross-sectional	238			Pfz	Global	Sars-CoV 2 antibody (IgG)	Blood	Mean: 1088 [653;1847]	AU/mL		AU/mL	Nonspecified
						Pfz	1st Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 649 [485;855]	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 883	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 9670	AU/mL		AU/mL	Nonspecified
						Pfz	1st Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 3894	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 5635	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 10298	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 205	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 454	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 792	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 358	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 10232	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 4325	AU/mL		AU/mL	Nonspecified
da Silva, MC (Jan, 2023)	Brazil	Cross-sectional	175	Unvaccinated	34	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood					Alpha Delta Other
				Unvaccinated	34	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood					Alpha Delta Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	34	Pfz	Global	IgG-neutralizing antibodies	Blood					Alpha Delta Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	34	Pfz	Global	IgG-neutralizing antibodies	Blood					Alpha Delta Other
da Silva Filho, AO (Mar, 2023)	Brazil	Cross-sectional	162			Pfz	Global	Neutralization of live SARS-CoV-2	Blood					Omicron
Martínez-Quezada, R. (Jan, 2024)	Mexico	Cross-sectional	114			Pfz AZD AZDi SpV	Global	Neutralization of live SARS-CoV-2	Blood	Median: 250 [142.8;574.5]				Nonspecified
Romero-Ibarguengoitia, M.E (Feb, 2023)	Mexico	Cross-sectional	104			Pfz	Non-specified	Spike (S) antibody	Blood	Mean: 994.93 (3.08)	AU/mL		AU/mL	Nonspecified
						Mod	Non-specified	Spike (S) antibody	Blood	Mean: 669.55 (2.38)	AU/mL		AU/mL	Nonspecified
						AZDi	Non-specified	Spike (S) antibody	Blood	Mean: 385.37 (3)	AU/mL		AU/mL	Nonspecified
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		Pfz	Non-specified	Spike (S) antibody	Blood	Mean: 1062.13 (2.24)	AU/mL	Mean: 931.98 (4.2)	AU/mL	Nonspecified	1.14
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		Mod	Non-specified	Spike (S) antibody	Blood	Mean: 727.29 (2.42)		Mean: 601.99 (2.45)		Nonspecified	1.21
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		AZDi	Non-specified	Spike (S) antibody	Blood	Mean: 415.82 (3.39)	AU/mL	Mean: 338.27 (2.54)	AU/mL	Nonspecified	1.23
Treger, S (Apr, 2022)	Israel	Cross-sectional	28	Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Blood	Median: 145 [113;202]	AU/mL	Median: 41 [113;202]	AU/mL	Nonspecified	3.54
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Blood					Nonspecified
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Blood					Nonspecified
Conti, M (May, 2022)	United States	Cross-sectional	11	Types of population; Unvaccinated; Active or previous SARS-COV-2 infection	26	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 31.8	optical density (OD) ratios	Median: 5.8	optical density (OD) ratios	Nonspecified	5.48
				Types of population; Unvaccinated; Active or previous SARS-COV-2 infection	26	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgA)	Blood	Median: 1.2	optical density (OD) ratios	Median: 2.6	optical density (OD) ratios	Nonspecified	0.46
				Types of population; Unvaccinated; Active or previous SARS-COV-2 infection	10	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Breast milk	Median: 0.2	optical density (OD) ratios	Median: 0.1	optical density (OD) ratios	Nonspecified	2.00
				Types of population; Unvaccinated; Active or previous SARS-COV-2 infection	10	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgA)	Breast milk	Median: 1.1	optical density (OD) ratios	Median: 0.7	optical density (OD) ratios	Nonspecified	1.57
Kachikis, A. (Jan, 2024)	United States	Non-comparative Cohort	220			Nonspecified	Non-specified	Spike (S) antibody	Blood	Geometric Mean: 2070				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Geometric Mean: 674				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Geometric Mean: 8159				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Geometric Mean: 4299				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Geometric Mean: 1356				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Geometric Mean: 7141				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Adj Adjusted β coefficient :0.68 [0.13;1.23]		Adj Adjusted β coefficient :0.68 [0.13;1.23]		Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Blood	Adj Adjusted β coefficient :0.66 [0.1;1.22]		Adj Adjusted β coefficient :0.66 [0.1;1.22]		Nonspecified
Zilver, S.J.M. (Feb, 2023)	Netherlands	Non-comparative Cohort	178			Mod Pfz	Global	Spike (S) antibody	Blood	Median: 386 [181;848]	antispike IgG (BAU/ml)		antispike IgG (BAU/ml)	Nonspecified
						Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 101 [54;243]	RBD IgG (BAU/ml)		RBD IgG (BAU/ml)	Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Blood	Median: 5431 [3248;9222]	antispike IgG (BAU/ml)		antispike IgG (BAU/ml)	Nonspecified
						Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 4446 [2215;7380]	RBD IgG (BAU/ml)		RBD IgG (BAU/ml)	Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Blood	Median: 910 [455;2553]	antispike IgG (BAU/ml)		antispike IgG (BAU/ml)	Nonspecified
						Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 795 [385;2010]	RBD IgG (BAU/ml)		RBD IgG (BAU/ml)	Nonspecified
						Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 82 [29;218]	Neutralizin antibody levels (maternal) (IU/ml)		Neutralizin antibody levels (maternal) (IU/ml)	Nonspecified
						Mod Pfz	Global	anti spike IgA	Breast milk	Median: 466.5 [182;1428]	antispike IgA (BAU/ml)		antispike IgA (BAU/ml)	Nonspecified
						Mod Pfz	Global	RBD IgA	Breast milk	Median: 1663 [663;3805]	RBD IgA (BAU/mL)		RBD IgA (BAU/mL)	Nonspecified
Hayashi, T. (May, 2024)	Japan	Non-comparative Cohort	148			Other	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood					Omicron
Kugelman, N. (Dec, 2021)	Israel	Non-comparative Cohort	129			Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 1185.2	AU/mL		AU/mL	Nonspecified
Shen, C (Jun, 2024)	Taiwan;China	Non-comparative Cohort	127			Mod Pfz AZD	Global	RBD Antigen-specific ELISA (IgG)	Blood					Nonspecified
Prabhu, M. (Aug, 2021)	United States	Non-comparative Cohort	122			Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
						Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
Pérez-Bernal, M (May, 2024)	Cuba	Non-comparative Cohort	104			SBP	Global	RBD Antigen-specific ELISA (IgG)	Breast milk					Omicron Other
						SBP	Global	RBD Antigen-specific ELISA (IgG)	Breast milk					Omicron Other
Kugelman, N (May, 2022)	Israel	Non-comparative Cohort	102			Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 13681 [5718;18095]	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 10198	AU/ml		AU/ml	Nonspecified
				women without systemic side effects after the 3rd vaccine	81	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 19641 [7864;40000]	AU/ml	Median: 9622 [7864;40000]	AU/ml	Nonspecified	2.04
				normal weight women (BMI < 25 kg/m2 )		Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 11506 [6664;19399]	AU/ml	Median: 7861 [6664;19399]	AU/ml	Nonspecified	1.46
Proto, A. (Apr, 2024)	Italy	Non-comparative Cohort	98			Mod Pfz	Global	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
Cassidy, A (Jul, 2023)	United States	Non-comparative Cohort	76			Mod Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 2013 [1426;4062]	relative fluorescent units (RFU)		relative fluorescent units (RFU)	Nonspecified
						Mod Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 894 [443;1381]	relative fluorescent units (RFU)		relative fluorescent units (RFU)	Nonspecified
						Mod Pfz	1st Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 305 [199;425]	relative fluorescent units (RFU)		relative fluorescent units (RFU)	Nonspecified
Chen, W (Mar, 2024)	Taiwan;China	Non-comparative Cohort	71			Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood					Nonspecified
Rottenstreich, A. (May, 2022)	Israel	Non-comparative Cohort	69			Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 1049	NT 50		NT 50	Other
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 165	NT 50		NT 50	Delta
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 30	NT 50		NT 50	Omicron
						Pfz	1st Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 16	NT 50		NT 50	Other
						Pfz	2nd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Geometric Mean: 76	NT 50		NT 50	Other
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 8	NT 50		NT 50	Delta
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 673	NT 50		NT 50	Other
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Geometric Mean: 43	NT 50		NT 50	Delta
Mahyuddin, A (May, 2024)	Singapore	Non-comparative Cohort	62			Mod Pfz SIN	Global	Neutralization of live SARS-CoV-2	Blood					Delta Omicron
Chao, A. S. (Apr, 2024)	Taiwan;China	Non-comparative Cohort	62			Mod	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
Kalafat, E (May, 2024)	Turkey	Non-comparative Cohort	60			Pfz CRV	Global	Neutralization of live SARS-CoV-2	Blood					Nonspecified
Ben-Mayor Bashi, T (Nov, 2021)	Israel	Non-comparative Cohort	58			Pfz	3rd Tr	Spike (S) antibody	Blood	Median: 3386.3 [777.9;11340.4]	AU/ml		AU/ml	Alpha
						Pfz	3rd Tr	Spike (S) antibody	Blood	Median: 25.3 [1.1;209.2]	AU/ml		AU/ml	Alpha
Sievers B.L. (Mar, 2022)	United States	Non-comparative Cohort	33			Mod Pfz	Non-specified	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood					Beta Delta Omicron Other
Collier, A.R.Y (May, 2021)	United States	Non-comparative Cohort	30	Unvaccinated; Non-pregnant	28	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Median: 27601	Median of antibodies		Median of antibodies	Alpha Beta
				Unvaccinated; SARS-COV2 infection	13	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Other	Median: 14953	Median of antibodies	Median: 1342	Median of antibodies	Alpha Beta	11.14
				Unvaccinated; SARS-COV2 infection	14	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 19873	Median of antibodies	Median: 635	Median of antibodies	Alpha Beta	31.30
				Unvaccinated; SARS-COV2 infection	6	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Breast milk	Median: 97	Median antibody titer	Median: 203	Median antibody titer	Alpha Beta	0.48
				Unvaccinated; SARS-COV2 infection	9	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Other	Median: 25055	Median antibody titer	Median: 1593	Median antibody titer	Alpha Beta	15.73
				Unvaccinated; SARS-COV2 infection	9	Mod Pfz	Global	Sars-CoV 2 antibody (IgA)	Other	Median: 820	Median antibody titer	Median: 152	Median antibody titer	Alpha Beta	5.39
				Unvaccinated; SARS-COV2 infection	6	Mod Pfz	Global	Sars-CoV 2 antibody (IgA)	Breast milk	Median: 25	Median antibody titer	Median: 1940	Median antibody titer	Alpha Beta	0.01
						Mod Pfz	Global	Elispot data		Median: 270	Spot-forming cells per million PBMC		Spot-forming cells per million PBMC	Alpha Beta
						Mod Pfz	Global	T-cell responses			% IFN-γ per CD4		% IFN-γ per CD4	Alpha Beta
Shen, CJ (Jan, 2022)	Nonspecified	Non-comparative Cohort	29			Mod	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Median: 97.46 [97.18;97.73]	% of inhibition of neutralising antibodies		% of inhibition of neutralising antibodies	Other
						Mod	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Median: 80.49 [55.78;85.5]	% of inhibition of neutralising antibodies		% of inhibition of neutralising antibodies	Delta
Govindaraj, S (Jul, 2023)	United States	Non-comparative Cohort	24			Mod Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 15042				Other
						Mod Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 5807				Omicron Other
						Mod Pfz	2nd Tr; 3rd Tr	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 457				Other
						Mod Pfz	2nd Tr; 3rd Tr	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 246				Delta
						Mod Pfz	2nd Tr; 3rd Tr	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood	Median: 49				Omicron
Hantoushzadeh, S (Jun, 2023)	Iran;Islamic Rep.	Non-comparative Cohort	23	Versus other COVID-19 vaccine exposure	12	SIN	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 1.74 [1.08;2.06]	The cut‐off point for IgG and IgM ratios (the optical concentration of the sample/internal calibrator) in the samples was ≥1.1	Median: 0.48 [1.08;2.06]	The cut‐off point for IgG and IgM ratios (the optical concentration of the sample/internal calibrator) in the samples was ≥1.1	Nonspecified	3.62
Craig, A. (Jan, 2023)	Nonspecified	Non-comparative Cohort	20			Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Blood					Delta
Bartsch, Y (Jan, 2022)	United States	Non-comparative Cohort	20			Mod Pfz	Non-specified	isotype immunity and Fc-mediated response	Blood					Alpha Beta Delta Omicron Other
Prahl, M (Jul, 2022)	United States	Non-comparative Cohort	20			Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 388.6 (224.8)	RFU		RFU	Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 3214 (1383)	RFU		RFU	Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 3235	RFU		RFU	Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Cord blood	Mean: 2243	RFU		RFU	Nonspecified
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Mean: 220.2	RFU		RFU	Nonspecified
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Mean: 296.6	RFU		RFU	Nonspecified
Zdanowski, W (Jun, 2022)	Poland	Non-comparative Cohort	16			Pfz	3rd Tr	Spike (S) antibody	Blood	Mean: 984.37 (689.4)	U/ml		U/ml	Nonspecified
Chen, W (Aug, 2023)	Taiwan;China	Non-comparative Cohort	11			Mod	Global	Neutralization of live SARS-CoV-2	Blood					Omicron
Pongsatha, S (Apr, 2023)	Thailand	Uncontrolled clinical trial	30			AZDi	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 1412.7 (603.6)				Nonspecified
						AZDi	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Median: 95.3 [88.5;96.9]				Other
						AZDi	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Median: 84.9 [62.2;97]				Delta
						AZDi	2nd Tr; 3rd Tr	Spike (S) antibody	Blood	Mean: 1127 (0.671)				Nonspecified
						AZDi	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgA)	Blood	Mean: 2369 (0.557)				Nonspecified
						AZDi	2nd Tr; 3rd Tr	IgM anti- spike	Blood	Mean: 1114 (0.533)				Nonspecified
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

Child

Table 11: Study characteristics and main results from studies that assessed immunogenicity outcomes related to COVID-19 Vaccines in childs

Authors	Countrya	Study design	Population exposed to COVID-19 Vaccine	Comparator	Population for comparator	Vaccine product (Dose)b	Trimester of vaccine exposurec	Outcome	Tissue	Experimental group primary result	Units experimental group	Control group primary result	Units control group	SARS-CoV-2 Variant	Ratio
Beharier, O. (May, 2021)	Israel	Comparative Cohort	92	Unvaccinated	66	Pfz	Non-specified	RBD Antigen-specific ELISA (IgG)	Cord blood					Nonspecified
				Active or previous SARS-COV-2 infection	65	Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood					Nonspecified
Ben-Mayor Bashi, T (Nov, 2021)	Israel	Non-comparative Cohort	58			Pfz	3rd Tr	Spike (S) antibody	Cord blood	Median: 2594 [428.3;6757.6]	AU/ml		AU/ml	Alpha
						Pfz	3rd Tr	Spike (S) antibody	Cord blood					Alpha
						Pfz	3rd Tr	Spike (S) antibody	Cord blood	Median: 1.1 [0;4.3]	AU/ml		AU/ml	Alpha
Kashani-Ligumsky,L (Sep, 2021)	Israel	Comparative Cohort	29	COVID-19 during pregnancy	29	Pfz	3rd Tr	Spike (S) antibody	Cord blood	Mean: 224.7 (64.3)	u/ml	Mean: 83.7 (91.6)	u/ml	Alpha	2.68
Mayo, R.P. (Nov, 2021)	Israel	Comparative Cohort	125	Unvaccinated; 212		Pfz	2nd Tr; 3rd Tr	IgM	Cord blood					Alpha Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	212	Pfz	2nd Tr; 3rd Tr	Fetal IgG - S1	Cord blood					Alpha Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	212	Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood					Alpha Other
				Unvaccinated; Non-previous SARS-CoV-2 infection	212	Pfz	2nd Tr; 3rd Tr	Fetal IgG - S2	Cord blood					Alpha Other
Nir,O (Jan, 2022)	Israel	Comparative Cohort	64	Active or previous SARS-COV-2 infection	11	Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 20.2 [12.7;29]		Median: 3.27 [12.7;29]		Nonspecified	6.18
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Other	Median: 11 [7.2;12.8]				Nonspecified
						Pfz	3rd Tr	placental SARS-CoV-2 IgG transfer ratio	Blood	Median: 0.77				Nonspecified
Prahl, M (Jul, 2022)	United States	Non-comparative Cohort	20			Mod Pfz	Global	Spike (S) antibody	Blood	Mean: 1290	RFU		RFU	Nonspecified
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Blood	Mean: 154	RFU		RFU	Nonspecified
Shen, CJ (Jan, 2022)	Nonspecified	Non-comparative Cohort	29			Mod	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Median: 97.37 [97.05;97.59]	% of inhibition of neutralising antibodies		% of inhibition of neutralising antibodies	Other
						Mod	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Median: 66.25 [44.68;75.22]	% of inhibition of neutralising antibodies		% of inhibition of neutralising antibodies	Delta
						Mod	3rd Tr	Transplacental antibody transfer for Neutralizing Antibody	Cord blood	Median: 0.99 [0.99;1]	transfer ratio		transfer ratio	Other
						Mod	3rd Tr	Transplacental antibody transfer for Neutralizing Antibody	Cord blood	Median: 0.9 [0.78;0.95]	transfer ratio		transfer ratio	Delta
Trostle, M.E. (Nov, 2021)	United States	Non-comparative Cohort	36			Mod Pfz	Global	Spike (S) antibody	Cord blood					Nonspecified
						Mod Pfz	Global	Spike (S) antibody	Cord blood					Nonspecified
Zdanowski, W (Jun, 2022)	Poland	Non-comparative Cohort	16			Pfz	3rd Tr	Spike (S) antibody	Cord blood	Mean: 1026.51 (769.25)	U/ml		U/ml	Nonspecified
Rottenstreich, A. (Feb, 2022)	Israel	Comparative Cohort	432	Versus other COVID-19 vaccine exposure	30	Pfz	1st Tr	Spike (S) antibody	Cord blood	Median: 126	AU/ml	Median: 528	AU/ml	Nonspecified	0.24
				Versus other COVID-19 vaccine exposure	30	Pfz	1st Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 1140	AU/ml	Median: 4225	AU/ml	Nonspecified	0.27
						Pfz	2nd Tr	Spike (S) antibody	Cord blood	Median: 204	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 3809	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	Spike (S) antibody	Cord blood	Median: 255	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 8038	AU/ml		AU/ml	Nonspecified
						Pfz	1st Tr	Neutralizing SARS-CoV-2 antibody level	Blood	Median: 34	median NT50		median NT50	Nonspecified
						Pfz	2nd Tr	Neutralizing SARS-CoV-2 antibody level	Blood	Median: 191	median NT50		median NT50	Nonspecified
						Pfz	3rd Tr	Neutralizing SARS-CoV-2 antibody level	Blood	Median: 391	median NT50		median NT50	Nonspecified
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection; late 3rd trimester (32-36 weeks)		Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Blood	Median: 9516	AU/ml	Median: 6811	AU/ml	Nonspecified	1.40
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection; late 3rd trimester (32-36 weeks)		Pfz	3rd Tr	Transplacental transfer for anti-RBD-specific IgG	Blood	Median: 2.4	placental transfer ratio	Median: 0.8	placental transfer ratio	Nonspecified	3.00
Kugelman, N. (Dec, 2021)	Israel	Non-comparative Cohort	129			Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 3315.7	AU/mL		AU/mL	Nonspecified
Otero, S (Jan, 2023)	United States	Comparative Cohort	99	Unvaccinated; COVID 19 during pregnancy	136	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 17.38 [7.6;31.26]	AU/ml	Median: 1.28 [7.6;31.26]	AU/ml	Nonspecified	13.58
				Unvaccinated; Active or previous SARS-COV-2 infection	234	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood					Nonspecified
				Unvaccinated; COVID 19 during pregnancy	234	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 19.79	AU/ml	Median: 1.82	AU/ml	Nonspecified	10.87
				Unvaccinated; COVID 19 during pregnancy	234	Mod Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 12.57	AU/ml	Median: 1.36	AU/ml	Nonspecified	9.24
				Unvaccinated; COVID 19 during pregnancy	234	Mod Pfz	2nd Tr; 3rd Tr	Transplacental antibody transfer for Sars-Cov2 IgG	Blood	Median: 0.92	Transfer ratio in the ≤ 90 day timeframe	Median: 0.94	Transfer ratio in the ≤ 90 day timeframe	Nonspecified	0.98
				Unvaccinated; COVID 19 during pregnancy	234	Mod Pfz	2nd Tr; 3rd Tr	Transplacental antibody transfer for Sars-Cov2 IgG	Blood	Median: 2.84	Transfer ratio in the > 90 day timeframe	Median: 1.37	Transfer ratio in the > 90 day timeframe	Nonspecified	2.07
Shook, L (Feb, 2022)	United States	Comparative Cohort	77	Unvaccinated; Active or previous SARS-COV-2 infection	12	Mod Pfz	2nd Tr; 3rd Tr	Spike (S) antibody	Cord blood	Mean: 2.17 (0.5)	OD 450-570	Mean: 1 (0.83)	OD 450-570	Nonspecified	2.17
						Mod Pfz	2nd Tr; 3rd Tr	Spike (S) antibody	Blood	Mean: 1.29 (0.53)	OD 450-570		OD 450-570	Nonspecified
				Unvaccinated; Active or previous SARS-COV-2 infection	12	Mod Pfz	2nd Tr; 3rd Tr	Spike (S) antibody	Blood	Mean: 0.33 (0.46)	OD 450-570	Mean: 0 (0.01)	OD 450-570	Nonspecified
Nevo, L. (Sep, 2022)	Israel	Comparative Cohort	174	Unvaccinated; Active or previous SARS-COV-2 infection	17	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 4891.5 [2210.6;7535]	AU/ml	Median: 171.7 [2210.6;7535]	AU/ml	Nonspecified	28.49
				Unvaccinated; Active or previous SARS-COV-2 infection	17	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 2036.2 [946.7;4096.6]	AU/ml	Median: 171.7 [946.7;4096.6]	AU/ml	Nonspecified	11.86
Prabhu, M. (Aug, 2021)	United States	Non-comparative Cohort	122			Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood					Nonspecified
						Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood					Nonspecified
Conti, M (May, 2022)	United States	Cross-sectional	11	Types of population; Unvaccinated; Active or previous SARS-COV-2 infection	26	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 31.8	optical density (OD) ratios	Median: 0.18	optical density (OD) ratios	Nonspecified	176.67
				Types of population; Unvaccinated; Active or previous SARS-COV-2 infection	26	Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgA)	Cord blood	Median: 0.15	optical density (OD) ratios	Median: 0.09	optical density (OD) ratios	Nonspecified	1.67
Treger, S (Apr, 2022)	Israel	Cross-sectional	28	Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Cord blood	Median: 216 [155;316]	AU/mL	Median: 64 [155;316]	AU/mL	Nonspecified	3.38
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Transplacental antibody transfer for anti-S	Blood	Median: 1.48 [1.18;1.82]	Transfer ratio	Median: 1.35 [1.18;1.82]	Transfer ratio	Nonspecified	1.10
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Cord blood					Nonspecified
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Cord blood					Nonspecified
				Active or previous SARS-COV-2 infection	12	Pfz	2nd Tr	Spike (S) antibody	Cord blood					Nonspecified
Boelig R. (Mar, 2022)	United States	Comparative Cohort	49	Unvaccinated; Active or previous SARS-COV-2 infection	181	Nonspecified	Non-specified	Intracellular cytokines						Nonspecified
Kugelman, N (May, 2022)	Israel	Non-comparative Cohort	102			Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 13882 [11591;15398]	GMC AU/ml		GMC AU/ml	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 19221 [8352;26717]	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	SARS-CoV-2 IgG antibody transfer ratio	Cord blood	Median: 1.37 [0.97;2.01]	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood					Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
Matsui, Y. (May, 2022)	United States	Comparative Cohort	30	Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
				Unvaccinated; wild type	30	Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Mean: 211	mean nAb titer at 50% inhibition (NT50)	Mean: 78	mean nAb titer at 50% inhibition (NT50)	Other	2.71
Rottenstreich, A. (May, 2022)	Israel	Non-comparative Cohort	69			Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 720	NT 50		NT 50	Other
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 90	NT 50		NT 50	Delta
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 18	NT 50		NT 50	Omicron
						Pfz	1st Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 30	NT 50		NT 50	Other
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 194	NT 50		NT 50	Other
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 13	NT 50		NT 50	Delta
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 471	NT 50		NT 50	Other
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 31	NT 50		NT 50	Delta
Rottenstreich, A. (Jun, 2022)	Israel	Comparative Cohort	56			Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 4046 [2446;7896]	AU/ml		AU/ml	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 545 [344;810]	AU/mL		AU/mL	Nonspecified
						Pfz	1st Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 1595 [999;2482]	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 3809 [2980;6815]	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 6763 [3857;12561]	AU/mL		AU/mL	Nonspecified
						Pfz	1st Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 2020 [164;517]	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 530 [453;929]	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 598 [503;1033]	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 177	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood					Nonspecified
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 16	AU/ml		AU/ml	Nonspecified
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 35	AU/ml		AU/ml	Nonspecified
				fully breastfed 3-month-old infants, born to mothers with two-dose vaccine series within the first month after delivery	10	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood					Nonspecified
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood					Nonspecified
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood					Nonspecified
						Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood					Nonspecified
						Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 366	AU/ml		AU/ml	Nonspecified
Atyeo, C.G. (Jun, 2022)	United States	Comparative Cohort	158			Mod Pfz J&J	1st Tr	Transplacental antibody transfer for Sars-CoV 2 antibody (IgG)	Blood	Median: 1.5	transfer ratio		transfer ratio	Nonspecified
						Mod Pfz J&J	2nd Tr	Transplacental antibody transfer for Sars-CoV 2 antibody (IgG)	Blood	Median: 1.3	transfer ratio		transfer ratio	Nonspecified
						Mod Pfz J&J	3rd Tr	Transplacental antibody transfer for Sars-CoV 2 antibody (IgG)	Blood	Median: 1	transfer ratio		transfer ratio	Nonspecified
Kugelman, N. (May, 2022)	Israel	Comparative Cohort	242	Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	107	Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 8773.3 [5143.8;18830.9]	AU/ml	Median: 3280 [5143.8;18830.9]	AU/ml	Nonspecified	2.67
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	121	Pfz	2nd Tr	SARS-CoV-2 IgG antibody transfer ratio	Cord blood	Mean: 2.1 (0.5)				Nonspecified
						Pfz	2nd Tr	transplacental SARS-CoV-2 IgG antibody transfer ratio	Cord blood	Mean: 2.1 (0.5)	AU/ml		AU/ml	Nonspecified
Popescu, D. (May, 2022)	Romania	Comparative Cohort	91	Versus other COVID-19 vaccine exposure; COVID-19 disease during pregnancy before vaccine	26	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 2837.76 (3711.8) [1918.01;3757.52]	U/ml	Mean: 11414.9 (5046.56) [9376.55;13453.25]	U/ml	Nonspecified	0.25
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Blood	Mean: 5288.37 (5661.5) [4109.31;6467.44]	U/ml		U/ml	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood					Nonspecified
Chen, W. (Oct, 2022)	Taiwan;China	Comparative Cohort	20			Mod	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 0 [0;13.92]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 178.4 [131.62;236.61]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 207.58 [180.85;234.31]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 146.75 [114.19;195.52]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 188.03 [131.62;330.32]	ng/mL		ng/mL	Delta Other
						Mod	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 0 [0;0]	ng/mL		ng/mL	Omicron
Flannery, D. (Nov, 2022)	United States	Comparative Cohort	177	Unvaccinated; Active or previous SARS-COV-2 infection	408	Mod Pfz J&J	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 27.05	AU/ml	Geometric Mean: 2.97	AU/ml	Nonspecified	9.11
				Unvaccinated; Active or previous SARS-COV-2 infection; Asymptomatic	265	Mod Pfz J&J	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 27.05	AU/ml	Geometric Mean: 2.55	AU/ml	Nonspecified	10.61
				Unvaccinated; Active or previous SARS-COV-2 infection; Symptomatic	143	Mod Pfz J&J	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 27.05	AU/ml	Geometric Mean: 3.94	AU/ml	Nonspecified	6.87
				Unvaccinated; Active or previous SARS-COV-2 infection	408	Pfz	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 21.66	AU/ml	Geometric Mean: 2.97	AU/ml	Nonspecified	7.29
				Unvaccinated; Active or previous SARS-COV-2 infection	408	Mod	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 37.76	AU/ml	Geometric Mean: 2.97	AU/ml	Nonspecified	12.71
				Unvaccinated; Active or previous SARS-COV-2 infection	408	J&J	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 2.94	AU/ml	Geometric Mean: 2.97	AU/ml	Nonspecified	0.99
				Unvaccinated; Active or previous SARS-COV-2 infection	408	Nonspecified	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 49.25	AU/ml	Geometric Mean: 2.97	AU/ml	Nonspecified	16.58
Golan, N. (Dec, 2022)	Israel	Comparative Cohort	31			Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 214.6 [149.5;279.6]	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 245.6 [170.4;320.8]	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 85.7 [15;156.3]	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 240.4 [156.3;324.5]	AU/ml		AU/ml	Nonspecified
						Pfz	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 160.6 [70.1;221.4]	AU/ml		AU/ml	Nonspecified
Juttukonda, L. J (Sep, 2022)	United States	Comparative Cohort	17			Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 56808	AU/mL		AU/mL	Nonspecified
Sunder, A. (Oct, 2022)	Bahrain	Comparative Cohort	79	Versus other COVID-19 vaccine exposure	42	SIN	2nd Tr; 3rd Tr	Spike (S) antibody	Cord blood	Median: 50 [14.3;173]	U/mL	Median: 1484.5 [14.3;173]	U/mL	Nonspecified	0.03
				Versus other COVID-19 vaccine exposure	42	SIN	2nd Tr; 3rd Tr	Transplacental transfer of Anti-S antibodies	Cord blood	Median: 0.94 [0.22;1.59]	transfer ratio	Median: 1.28 [0.22;1.59]	transfer ratio	Nonspecified	0.73
Kugelman, N. (Dec, 2022)	Israel	Comparative Cohort	40			Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 2790.3 [350.1;13405]	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 199 [18.4;904.3]	AU/mL		AU/mL	Nonspecified
				Versus other COVID-19 vaccine exposure; nonbreastfed infants	12	Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 232 [105.7;904.3]	AU/mL	Median: 145.3 [105.7;904.3]	AU/mL	Nonspecified	1.60
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood					Nonspecified
Craig, A. (Jan, 2023)	Nonspecified	Non-comparative Cohort	20			Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood					Delta
Cahen-Peretz, A. (Jan, 2023)	Israel	Comparative Cohort	213	Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection	127	Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 11760.7 [6670.6;20211.5]	AU/mL	Median: 1747.2 [6670.6;20211.5]	AU/mL	Overall	6.73
Dude, C (Jan, 2023)	United States	Comparative Cohort	34	Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood					Nonspecified
				Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood					Nonspecified
				Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	Sars-CoV 2 antibody (IgA)	Cord blood					Nonspecified
				Active or previous SARS-COV-2 infection	18	Mod Pfz	Global	IgM anti SARS-CoV-2	Cord blood					Nonspecified
Romero-Ibarguengoitia, M.E (Feb, 2023)	Mexico	Cross-sectional	104			Pfz	Non-specified	Spike (S) antibody	Cord blood	Mean: 1316.43 (2.79)	AU/mL		AU/mL	Nonspecified
						Pfz	Non-specified	Spike (S) antibody	Blood	Mean: 1192.02 (3.55)	AU/mL		AU/mL	Nonspecified
						Mod	Non-specified	Spike (S) antibody	Cord blood	Mean: 846.59 (2.36)	AU/mL		AU/mL	Nonspecified
						Mod	Non-specified	Spike (S) antibody	Blood	Mean: 795.77 (2.39)	AU/mL		AU/mL	Nonspecified
						AZDi	Non-specified	Spike (S) antibody	Cord blood	Mean: 461.68 (2.95)	AU/mL		AU/mL	Nonspecified
						AZDi	Non-specified	Spike (S) antibody	Blood	Mean: 424.68 (2.57)	AU/mL		AU/mL	Nonspecified
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		Pfz	Non-specified	Spike (S) antibody	Cord blood	Mean: 1759.31 (1.73)	AU/mL	Mean: 985.04 (3.81)	AU/mL	Nonspecified	1.79
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		Pfz	Non-specified	Spike (S) antibody	Blood	Mean: 1701.1 (1.7)	AU/mL	Mean: 835.3 (5.5)	AU/mL	Nonspecified	2.04
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		Mod	Non-specified	Spike (S) antibody	Cord blood	Mean: 929.79 (2.48)	AU/mL	Mean: 750.46 (2.32)	AU/mL	Nonspecified	1.24
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		Mod	Non-specified	Spike (S) antibody	Blood	Mean: 904.15 (2.46)	AU/mL	Mean: 675.3 (2.38)	AU/mL	Nonspecified	1.34
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		AZDi	Non-specified	Spike (S) antibody	Cord blood	Mean: 472.32 (3.44)	AU/mL	Mean: 443.99 (2.34)	AU/mL	Nonspecified	1.06
				Versus other COVID-19 vaccine exposure; Non-previous SARS-CoV-2 infection		AZDi	Non-specified	Spike (S) antibody	Blood	Mean: 438.46 (2.86)	AU/mL	Mean: 402.05 (2.22)	AU/mL	Nonspecified	1.09
Toussia-Cohen, S. (Nov, 2022)	Israel	Comparative Cohort	103			Nonspecified	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 109	Neonatal serum IgG (BAU/mL)		Neonatal serum IgG (BAU/mL)	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 322.6	Neonatal serum IgG (BAU/mL)		Neonatal serum IgG (BAU/mL)	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 1269	Neonatal serum IgG (BAU/mL)		Neonatal serum IgG (BAU/mL)	Nonspecified
						Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 103.9	Neonatal serum IgG (BAU/mL)		Neonatal serum IgG (BAU/mL)	Nonspecified
Abu Shqara, R (Jun, 2023)	Israel	Cross-sectional	238			Pfz	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 1471	AU/mL		AU/mL	Nonspecified
						Pfz	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 982				Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 2007	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 12477	AU/mL		AU/mL	Nonspecified
						Pfz	1st Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 6283	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 10237	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 18333	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 286	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 754	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 1098	AU/mL		AU/mL	Nonspecified
						Nonspecified	Non-specified	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 385	AU/mL		AU/mL	Nonspecified
						Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Mean: 12113	AU/mL		AU/mL	Nonspecified
						Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Geometric Mean: 8112	AU/mL		AU/mL	Nonspecified
Conyers, S (May, 2023)	United States	Comparative Cohort	77			Mod Pfz J&J	1st Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 5370				Nonspecified
						Mod Pfz J&J	2nd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 1255				Nonspecified
						Mod Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 2623				Nonspecified
				Unvaccinated; Active or previous SARS-COV-2 infection	6	Nonspecified	Non-specified	RBD Antigen-specific ELISA (IgG)	Cord blood			Median: 45		Nonspecified
						Mod Pfz J&J	1st Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 514				Nonspecified
						Mod Pfz J&J	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 1070				Nonspecified
						Mod Pfz J&J	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 2477				Nonspecified
						Mod Pfz J&J	1st Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 284				Omicron Other
						Mod Pfz J&J	2nd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 66				Omicron Other
						Mod Pfz J&J	3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 173				Omicron Other
				Unvaccinated; Active or previous SARS-COV-2 infection	6	Nonspecified	Non-specified	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 10				Omicron Other
						Mod Pfz J&J	1st Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 54				Omicron Other
						Mod Pfz J&J	2nd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 44				Omicron Other
						Mod Pfz J&J	3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 152				Omicron Other
da Silva Filho, AO (Mar, 2023)	Brazil	Cross-sectional	162			Pfz	Global	Neutralization of live SARS-CoV-2	Blood					Omicron
Dawood, F (Apr, 2023)	United States	Comparative Cohort	85			Mod Pfz	1st Tr	Neutralization of live SARS-CoV-2	Cord blood	Mean: 198 [63;624]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	2nd Tr	Neutralization of live SARS-CoV-2	Cord blood	Mean: 541 [305;961]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Cord blood	Mean: 1089 [483;2452]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	1st Tr; 2nd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 54 [24;122]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 98 [28;346]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	1st Tr; 2nd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 7 [4;13]	AU/mL		AU/mL	Nonspecified
						Mod Pfz	3rd Tr	Neutralization of live SARS-CoV-2	Blood	Mean: 13 [5;33]	AU/mL		AU/mL	Nonspecified
Lubrano, C. (Apr, 2023)	Italy	Comparative Cohort	127	Unvaccinated	45	Mod Pfz AZD	Non-specified	Spike (S) antibody	Cord blood					Nonspecified
				Unvaccinated	6	Mod Pfz AZD	Non-specified	Th1 (IFNy-expressing T-cells)						Nonspecified
Mendenhall, E (Mar, 2023)	United States	Comparative Cohort	32	Unvaccinated	65	Mod Pfz	Non-specified	Sars-CoV 2 antibody (IgG)	Blood					Nonspecified
Pongsatha, S (Apr, 2023)	Thailand	Uncontrolled clinical trial	30			AZDi	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 1322.5 (721.8)				Nonspecified
						AZDi	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Median: 91.9 [77.5;96.5]				Other
						AZDi	2nd Tr; 3rd Tr	Neutralization of live SARS-CoV-2	Blood	Median: 73.2 [59.8;88.8]				Delta
						AZDi	2nd Tr; 3rd Tr	Spike (S) antibody	Blood	Mean: 1018 (0.647)				Nonspecified
						AZDi	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgA)	Blood	Mean: 0.804 (0.531)				Nonspecified
						AZDi	2nd Tr; 3rd Tr	IgM anti- spike	Blood	Mean: 0.005 (5e-04)				Nonspecified
Zilver, S.J.M. (Feb, 2023)	Netherlands	Non-comparative Cohort	178			Mod Pfz	Global	Spike (S) antibody	Cord blood	Median: 1932 [992;4112]	antispike in venous cord blood (BAU/ml)		antispike in venous cord blood (BAU/ml)	Nonspecified
						Mod Pfz	Global	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 1550 [858;3589]	RBD IgG antibodies in venous cord blood (BAU/ml)		RBD IgG antibodies in venous cord blood (BAU/ml)	Nonspecified
						Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 153 [71;400]	neutralizing antibody levels in cord blood (IU/mL)		neutralizing antibody levels in cord blood (IU/mL)	Nonspecified
Cassidy, A (Jul, 2023)	United States	Non-comparative Cohort	76			Mod Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Median: 851 [611;1465]	relative fluorescent units (RFU)		relative fluorescent units (RFU)	Nonspecified
						Mod Pfz	2nd Tr	Sars-CoV 2 antibody (IgG)	Blood	Mean: 356	relative fluorescent units (RFU)		relative fluorescent units (RFU)	Nonspecified
Chayachinda, Ch (Aug, 2023)	Thailand	Controlled clinical trial	124			Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 563.11	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 494.89	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 488.33	BAU/mL		BAU/mL	Nonspecified
						Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Geometric Mean: 519.4	BAU/mL		BAU/mL	Nonspecified
Govindaraj, S (Jul, 2023)	United States	Non-comparative Cohort	24			Mod Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 20785				Other
						Mod Pfz	2nd Tr; 3rd Tr	RBD Antigen-specific ELISA (IgG)	Cord blood	Median: 8674				Omicron Other
						Mod Pfz	2nd Tr; 3rd Tr	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 401				Other
						Mod Pfz	2nd Tr; 3rd Tr	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 266				Delta
						Mod Pfz	2nd Tr; 3rd Tr	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 49				Omicron
Hantoushzadeh, S (Jun, 2023)	Iran;Islamic Rep.	Non-comparative Cohort	23	Versus other COVID-19 vaccine exposure	11	SIN	2nd Tr; 3rd Tr	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 1.47 [0.82;2.58]	The cut‐off point for IgG and IgM ratios (the optical concentration of the sample/internal calibrator) in the samples was ≥1.1	Median: 0.48 [0.82;2.58]	The cut‐off point for IgG and IgM ratios (the optical concentration of the sample/internal calibrator) in the samples was ≥1.1	Nonspecified	3.06
Munoz, F. (Jun, 2023)	United States	Comparative Cohort	240			Mod Pfz	Global	Spike (S) antibody	Cord blood	Geometric Mean: 3290	BAU/mL		BAU/mL	Nonspecified
						Pfz	Global	Spike (S) antibody	Cord blood	Geometric Mean: 369	BAU/mL		BAU/mL	Nonspecified
						Mod	Global	Spike (S) antibody	Cord blood	Geometric Mean: 792	BAU/mL		BAU/mL	Nonspecified
				Versus other COVID-19 vaccine exposure	75	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Adj PR:1.04 [1;1.09]		Adj PR:1.04 [1;1.09]		Other
				Versus other COVID-19 vaccine exposure	75	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Adj PR:1.22 [1.11;1.33]		Adj PR:1.22 [1.11;1.33]		Delta
				Versus other COVID-19 vaccine exposure	75	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Adj PR:3.71 [2.53;5.44]		Adj PR:3.71 [2.53;5.44]		Omicron
				Versus other COVID-19 vaccine exposure	75	Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Adj PR:1 [1;1]		Adj PR:1 [1;1]		Other
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 742.5				Other
						Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 77.1				Other
						Mod	Global	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 134.7				Other
						Mod Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 109.2				Omicron Other
						Pfz	Global	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 13.3				Omicron Other
						Mod	Global	Neutralization of live SARS-CoV-2	Cord blood	Geometric Mean: 14.6				Omicron Other
						Mod Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Geometric Mean: 941				Nonspecified
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Geometric Mean: 159				Nonspecified
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Geometric Mean: 359				Nonspecified
Murphy, E (Aug, 2023)	United States	Comparative Cohort	2,491			Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.6	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.9	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 4.1	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.4	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.6	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.9	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.2	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.3	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod Pfz J&J	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.4	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 4	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 4.1	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.8	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 4.1	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.6	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.8	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.7	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.9	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.2	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.3	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.3	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.5	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.6	Umbilical cord B.1(log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1(log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.6	Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord B.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.5	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.4	Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.1 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Mod	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.2	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
						Pfz	Global	Neutralization of a pseudovirus modified to express SARS-CoV-2 antigens	Cord blood	Median: 3.2	Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection		Umbilical cord BA.5 (log10) - Neutralizing activity in umbilical cord blood of neonates born to patients with a positive history of SARS-CoV-2 infection	Omicron Other
Kachikis, A. (Jan, 2024)	United States	Non-comparative Cohort	220			Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Geometric Mean: 2817				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Geometric Mean: 1000				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Geometric Mean: 9992				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Geometric Mean: 5090				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Geometric Mean: 1460				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Geometric Mean: 8818				Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Adj Adjusted β coefficient :0.46 [0.03;0.95]		Adj Adjusted β coefficient :0.46 [0.03;0.95]		Nonspecified
						Nonspecified	Non-specified	Spike (S) antibody	Cord blood	Adj Adjusted β coefficient :0.44 [0.06;0.94]		Adj Adjusted β coefficient :0.44 [0.06;0.94]		Nonspecified
Martínez-Quezada, R. (Jan, 2024)	Mexico	Cross-sectional	114			Pfz AZD AZDi SpV	Global	Sars-CoV 2 antibody (IgG)	Cord blood	Median: 1497 [0.61;2.2]				Nonspecified
						Pfz AZD AZDi SpV	Global	Neutralization of live SARS-CoV-2	Cord blood	Median: 336.3 [137.1;570.4]				Nonspecified
Lopez, P (Mar, 2024)	United States	Non-comparative Cohort	100			Mod Pfz J&J	Global	Spike (S) antibody	Blood					Alpha Beta Delta Omicron
(-)	United Kingdom, Spain, South Africa, Brazil, United States	Controlled clinical trial	173	Placebo; Non-previous SARS-CoV-2 infection	69	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 311.1		Geometric Mean: 22		Nonspecified	14.14
				Placebo; Non-previous SARS-CoV-2 infection	92	Pfz	3rd Tr	Sars-CoV 2 antibody (IgG)	Blood	Geometric Mean: 5576.4		Geometric Mean: 19.4		Nonspecified	287.44
aRegion categorization according to WHO:African Region (AFR), Eastern Mediterranean Region (EMR), European Region (EUR), Region of the Americas (AMR), South-East Asian Region (SEAR), Western Pacific Region (WPR)
bNVX=rCV or NVX-CoV2373,NVXi=COVOVAX or NVX-CoV2373,Mod=mRNA-1273,Pfz=mRNA-CV or BNT162b2,J&J=Ad36,COV2,S,AZD=ChAdOx1-S,AZDi=ChAdOx1_nCoV-19 or Covishield,BBV=BBV152 COVAXIN,SIN=WIBP-CorV or BBIBP-CorV,CSN=Ad5-nCoV,CRV=Coronavac,SAN=CoV2 preS dTM-AS03 vaccine,CPG=SCB-2019 or CpG 1018/Alum,ZFV=ZF2001 or ZIFIVAX or ZF-UZ-VAC 2001,SpV=Gam-COVID-Vac,EVC=EpiVakKorona or EpiVacCorona,IMB=Covidful or SARS-CoV-2 Vaccine, Inactivated (Vero Cell),SB1=Soberana 01,SB2=Soberana 02,SBP=Soberana Plus,ABD=Abdala or CIGB-66
cFirst trimester: 0-12 weeks; Second trimester: 13-27 weeks; Third trimester: >27 weeks ; Global: The study included pregnant persons vaccinated during the first, second and third trimester; Nonspecified: The study does not provide information regarding in which trimester the vaccine products were administered

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