Safe in Pregnancy

Ongoing
Project

Landscape analysis: Sentinel Site Readiness for Maternal Immunization Active Safety Surveillance in LMICs

We will define the landscape for integrated maternal immunization active safety surveillance by reviewing the literature, building consensus among experts, and identifying potential sentinel sites in low- and middle-income countries (LMICs). We will perform a scoping review of the literature and organize an expert meeting to identify existing individual-level data collection systems which could inform integrated active safety surveillance. In a next step, we will build consensus about a minimum basic data set using a three-stage modified Delphi method, starting with two rounds of individual and anonymous online questionnaires, followed by a third round: an in-person group discussion. We will perform visits to up to three potential sentinel sites to assess existing data collection systems and interview key informants. Our goal is to have sites ready for deployment of an integrated active safety surveillance system for introducing novel interventions in pregnancy, including novel maternal vaccines.

Steering
Committee

Pierre Buekens, MD, PhD
W.H. Watkins Professor of Epidemiology
Tulane School of Public Health and Tropical Medicine

Fernando Althabe, MD, MSc
Medical Officer, Maternal and Perinatal and Preventing Unsafe Abortion Team
World Health Organization
(observer)

Amanda "Mabel" Berrueta, MD
Researcher, Department of Mother and Child Health Research
Instituto de Efectividad Clínica Sanitaria

Andy Stergachis, PhD
Director, Global Medicines Program
University of Washington

Ajoke Sobanjo-ter Meulen, MD, MSc
Global Head of Maternal Immunization
Bill & Melinda Gates Foundation
(observer)

Advisory
Board

Judith Absalon, MD, MPH, FIDSA
Vaccine Research & Development, Pfizer, Inc.

Steve Anderson, PhD, MPP
Director, Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research (CBER)
U.S. Food & Drug Administration

Elizabeth McClure, PhD
Senior Research Epidemiologist
Social, Statistical, and Environmental Health Sciences
RTI International

Shabir Madhi, PhD
Professor of Vaccinology
University of Witwatersrand

Flor M. Munoz, MD
Associate Professor of Pediatrics, Infectious Diseases
Molecular Virology and Microbiology
Baylor College of Medicine

Kissa W. Mwamwitwa-Mbwana
Tanzania Medicines and Medical Devices Authority (TMDA)

Annettee Nakimuli, MD
Department of Obstetrics and Gynaecology, School of Medicine
Makerere University College of Health Sciences

Jennifer Clark Nelson, PhD
Senior Investigator and Director of Biostatistics
Kaiser Permanente Washington Health Research Institute

Lisa Noguchi, PhD, CNM
Director, Maternal and Newborn Health
Jhpiego

Lakshmi Panagiotakopoulos, MD
Immunization Safety Office
Centers for Disease Control and Prevention

Esperanca Sevene, PhD
Associate Professor
Department of Physiological Science, Clinical Pharmacy
Faculty of Medicine
Universidade Eduardo Mondlane (UEM)

Patrick Zuber, MD
Group Lead, Safety/Vaccines
Essential Medicines and Health Products
World Health Organization
(observer)