Objectives:

  1. Describe approaches for the evaluation of COVID-19 vaccine candidates for use in pregnant women and their infants, from pre-licensure clinical studies to the post-licensure period;
  2. Create an evaluation framework for COVID-19 vaccine candidates for use in pregnant and lactating women; and
  3. Describe the necessary data and studies to close the availability and access gap to safe and effective COVID-19 vaccination and prevention strategies for pregnant and lactating women.

Workstream 1. Vaccine Candidate Mapping / Key Characteristics - Lead: Dr. Emily Erbelding, US NIH
  • Review of COVID-19 vaccine candidates
  • Expert consultations
  • Summary of key characteristics of COVAX supported COVID-19 vaccine candidates and data mapping as pertinent to maternal immunization 

  Emily Erbelding (Lead), Director, Divison of Microbiology and Infectious Diseases NIH - ACTIV; US
  Ajoke Sobanjo-ter Meulen, Senior Program Officer, Bill & Melinda Gates Foundation; US
  Karin Bok, Senior Advisor Vaccine Development, VRC, NIAID, NIH; US
  Anh Wartel, Associate Director General of Clinical Development, IVI, South Korea
  Angela Gentile, Head, Department of Epidemiology, Ricardo Gutiérrez Children's Hospital; Argentina
  Gerald Voss, Scientific Director of the TuBerculosis Vaccine Initiative/CEPI; Belgium
  Johan Vekemans, SARS-CoV-2 vaccine Global Clinical Head, AstraZeneca; Belgium
  Titilope Oduyebo, CDC; US, ACOG, IIFPHPEWG

Workstream 2. Pre-clinical / Clinical Data - Lead: Prof. Beate Kampmann, LSHTM
  • Identification of key questions and date needs for the pre-clinical and clinical assessment of vaccine candidates for maternal immunization.
  • Discussion forum with invited presentations and expert consultations to inform the working group on various topics including burden and impact of COVID-19 in pregnancy, placental physiology, the fetus and newborn, clinical development, ethics, and regulatory considerations.
  • Survey of working group members on key questions with collection and evaluation of responses.
  • Discussion and consensus among the full working group.

  Beate Kampmann (Lead), Professor of Paediatric Infection & Immunity, Director of the Vaccine Centre; London School of Health and Tropical Medicine; UK
  Flor Munoz-Rivas, Associate Professor, Pediatrics-Infectious Disease; Baylor College of Medicine; US
  Geeta Swamy, Associate Professor of Obstetrics and Gynecology, Duke University School of Medicine; US
  Clare Cutland, Lecturer, University og the Witwatersand; South Africa
  Asma Khalil, Professor, Consultant obstetrician at St George's Hospital; UK
  Helen Marshall, Medicail Director VIRTU & A-Prof Vaccinology / Affiliate Lecturer, Women's and Children's Health/Public Health, University of Adelaide; Australia
  Chrissie Jones, Associate Professor in Paediatric Infectious Diseases and Immunology, University of Southampton; UK
  Sylvanus Okogbenin, Professor, Consultant Obstetitrican, Irrua Specialist Teaching Hospital; Nigeria
  Judith Absalon, Senior Director, Vaccines Clinical Research, Pfizer; US

Workstream 3. Vaccine Safety - Leads: Prof. Andy Stergachis, University of Washington; Dr. Steve Anderson, US FDA
  • Identification of pregnancy safety considerations for four vaccine development scenarios:
    • Pregnant women not included in pre-licensure clinical trials, i.e. excluded from clinical trials.
    • Pregnanct women included in pre-licensure clinical trials.
    • Separate pre- (or post-) licensure clinical trial specifically designed for pregnant women.
    • Post-licensure safety surveillance. 
  • Review and consideration of key regulatory and WHO guidance documents pertaining to pregnancy safety studies.
  • Development and administration of a survey of the Advisory Board members of the project, "Sentinel Site Readiness for Maternal Immunization Active Safety Surveillance in LMICs (Lead: Prof. Pierre Buekens, Tulane University)," with collection and evaluation of written responses. 

  Stephen Anderson (Lead), Director, Office of Biostatistics and Epidemiology CBER/WHO-GAVCS; US
  Andrew Stergachis (Lead), Professor, Global Health, Professor, Pharmacy Director, Global Medicines Program University of Washington, US
  Steve Black, CEPI-SPEAC; US
  Delese Mimi Darko, Chief Executive Office, Ghana Food and Drugs Authority; Ghana
  Christine Guillard-Maure, Global Vaccine Safety Initiative, WHO
  Esperanca Sevene, Associate Professor, Universidade Eduardo Mondlane; Mozambique

Cross-cutting Workstreams:
  • Review and input from ethics and regulatory experts across all workstreams.

Cross-cutting advisors

  Marion Gruber (Regulatory), Director, CEnter for Biologics Evaluation and Research (CBER) FDA; US
  Helen Rees (Regulatory), Professor, Wits Reproductive Health and HIV Institute, Board Chair SAHPRA; South Africa
  Ruth Karron (Ethics), Professor, John Hopkins Bloomberg School of Public Health; US
  Carleigh Krubiner (Ethics), Policy Fellow, Center for Global Development, Johns Hopkins University; US
  Daniel Brasseur (Regulatory/CEPI), Former CHMP-PDCO-VWP chair at EMA, CEPI consultant; EU