Should I get the COVID-19 vaccine while pregnant or breastfeeding? Experts explain the safety, evidence and clinical trials
By Terra Manca and Karina A Top
Since the COVID-19 pandemic began, public health communications put a special focus on helping high-risk populations, such as seniors, stay safe. Yet, information for pregnant or breastfeeding individuals has been inconsistent and hard to find. Though most pregnant people who become ill with COVID-19 have mild symptoms, pregnancy does
increase the risk of being admitted to
hospital and intensive care, as well as the risk of
preterm birth and dangerously high blood pressure.
We research vaccination in pregnant populations, including
ways to improve consistency in information. For example, information about vaccination during pregnancy contained in vaccine package inserts approved by Health Canada may differ from the recommendations of the Canadian National Advisory Committee on Immunization (NACI).
Gaps in data contributed to caution regarding COVID-19 vaccination during pregnancy in the National Advisory Committee on Immunization’s initial recommendations. THE CANADIAN PRESS/Jonathan Hayward
Inconsistencies in information about COVID-19 vaccination arose because pregnant and breastfeeding people
were initially excluded from gold-standard randomized clinical trials. Experts in reproductive health, vaccination and medicine have
developed guidelines for ethically including pregnant and breastfeeding people in vaccine development and deployment. These guidelines were available before the COVID-19 pandemic and could have informed early COVID-19 vaccine development.
The reasons for excluding pregnant and breastfeeding people from trials are complex. They may include fear or legal concerns about
harming the fetus or infant. In the case of COVID-19 vaccines, the “need for speed”
made clinical development the top priority. That meant proceeding with trials before completing the pre-clinical requirements for involving pregnant participants in clinical trials. These prerequisites include animal studies on the effects of COVID-19 vaccines on fetal development and reproduction.
Inconsistent messages
As more information became available demonstrating the safety of vaccination in pregnancy, these guidelines have been updated and are now more closely aligned.
Lack of information made it difficult for health-care and other essential workers who were pregnant or breastfeeding to make decisions about COVID-19 vaccination. (Shutterstock)
The highest quality evidence should have been available to inform vaccine policies, recommendations and individuals’ decisions about whether to receive a vaccine while pregnant or breastfeeding.
Health-care and other essential workers who were pregnant or breastfeeding had a difficult decision to make. They had to weigh the known dangers of COVID-19 against uncertainties about vaccine safety information in the early weeks of vaccine rollout. Exclusion from clinical trials left these front-line workers to make decisions about COVID-19 vaccines based on incomplete information.
Good quality information is now available
Evidence is now available to show that COVID-19 vaccines are safe for people who are pregnant or breastfeeding and their infants. More than 130,000 people who received COVID-19 vaccines while pregnant or breastfeeding have joined the
V-safe registry in the United States. Most received Pfizer/BioNTech or Moderna mRNA vaccines.
Initial findings from that registry have been published, showing no safety concerns so far.
Long-term followup
Earlier access to data about vaccination while pregnant or breastfeeding is needed to develop equitable public health guidelines. Pregnant and breastfeeding people include front-line workers at greater risk of exposure to COVID-19 and other viruses.
As we take stock of our response to this pandemic, it is important to consider the implications of excluding pregnant and breastfeeding people from clinical trials and consider how we can do better next time.
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