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Pregnant women, their fetuses and infants are at increased risk of severe disease and death from many diseases like COVID-19 that could be prevented with vaccines. Yet, they are typically excluded from research aimed at generating data to support decision-making when it comes to vaccine implementation.

In a new paper published today in Lancet, researchers at Dalhousie University say the time has come to end that practice and include pregnant and breastfeeding women in early vaccine research, while removing real and perceived barriers to responsible inclusion.

Karina Top, an associate professor in Dal's Department of Pediatrics and researcher with the Canadian Center for Vaccinology; Francoise Baylis, a University Research Professor in Philosophy at Dal; and post-doctoral fellow, Terra Manca, co-authored the commentary that outlines how pregnant women have historically been excluded from research initiatives despite repeated calls from various health groups, clinicians and regulators for their inclusion.

The commentary states that for the most part, pregnant and breastfeeding women were not included in pre-implementation clinical trials of SARS-CoV-2 vaccines. Trials involving pregnant women began only after emergency use authorization of the vaccines was granted, but many were not completed due to a lack of participants.

The authors note that some countries initially advised against vaccinating pregnant and breastfeeding women against COVID-19, while others said vaccination could be offered to them despite the absence of clinical trial data. Yet, some health-care providers and women hesitated to accept these recommendations.

Dr. Top and Dr. Baylis are available to discuss measures that would ensure this vulnerable group is included in future vaccine trials at the outset to improve vaccine acceptance.

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Media contact:

Alison Auld 
Senior Research Reporter 
Communications, Marketing and Creative Services 
Dalhousie University 
Cell: 1-902-220-0491 
Email: alison.auld@dal.ca