The COVAX Maternal Immunization Working Group (MIWG): co-chaired by Drs. Flor M. Munoz (Baylor College of Medicine, USA) and Ajoke Sobanjo-ter Meulen (Bill & Melinda Gates Foundation, USA) includes a group of professionals with expertise in various aspects pertinent to maternal immunization, who represent diverse organizations, geographies, and settings. The aim of the MIWG is to enable the evaluation and utilization of COVID-19 vaccine candidates in pregnant and lactating women.

Co-Leads: Ajoke Sobanjo-Ter Meulen (BMGF), Flor Muñoz (Baylor College of Medicine) | List of members


        

COVAX > Clinical Development and Operation > Maternal Immunization > Policies & Guidelines

Policies, regulations and guidelines on trials in pregnant women


FDA   |   CDC   |   ACOG   |   RCOG   |   JCVI   |   EMA   |   WHO   |   MHRA   |   Other

 FDA (Food and Drug Administration, USA)

Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry  |  June 2020

Pregnant women: scientific and ethical considerations for inclusion in clinical trials; draft guidance for industry  |  April 2018

Back to the top

CDC (Center for Disease Control, USA)

Webinar 'What Every Clinician Should Know about COVID-19 Vaccine Safety and Effectiveness and How to Address Patient Questions and Concerns'  | 9 Mar 2021

Vaccination Considerations for People who are Pregnant or Breastfeeding  |  12 Feb 2021

Back to the top

ACOG (American Congress of Obstetricians and Gynecologists, USA)

Vaccinating Pregnant and Lactating Patients Against COVID-19  |  Last updated 28 Apr 2021

Back to the top

RCOG (Royal College of Obstetricians, UK)

RCOG COVID-19 vaccines, pregnancy and breastfeeding | 23 April 2021

RCOG statement in response to change in guidance around the Oxford Astra Zeneca vaccine  | 9 April 2021

Back to the top

JCVI (Joint Commitee on Vaccination and Immunisation, UK)

JCVI issues new advice on COVID-19 vaccination for pregnant women  |  16 April 2021

Back to the top

EMA (European Medicines Agency)

Workshop on benefit-risk of medicines used during pregnancy and breastfeeding | 22 Sep 2020 | Report

Guideline on the exposure to medicinal products during pregnancy: need for post-authorization data | May 2006

Back to the top

WHO (World Health Organization)

Strategic Advisory Group of Experts on Immunization (SAGE) Recommendations

Includes recommendations on pregnant and lactating women.

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects | 2002

UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials | July 2007

Back to the top

MHRA (Medical and Healthcare Products Regulatory Agency, UK)

Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy  | 18 Feb 2021

Back to the top