is a postdoctoral fellow with the Canadian Center for Vaccinology (IWK Health Centre) in the Department of Pediatrics at and is an associate professor in the Department of Pediatrics at
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 of being admitted to , as well as the risk of .
Currently, all Canadian provinces and territories . However, inconsistent information can lead to confusion among those looking to make informed decisions about vaccination for themselves and their families.
We research vaccination in pregnant populations, including 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).
Exclusion from trials
Inconsistencies in information about COVID-19 vaccination arose because pregnant and breastfeeding people from gold-standard randomized clinical trials. Experts in reproductive health, vaccination and medicine have 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 . In the case of COVID-19 vaccines, the 鈥渘eed for speed鈥� . 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.
Exclusion from trials has created inconsistencies between , and vaccine eligibility and prioritization in different provinces (, and ) about COVID-19 vaccination while pregnant or breastfeeding.
Inconsistent messages
Since May 2021, . However, gaps in data contributed to caution regarding COVID-19 vaccination during pregnancy in NACI鈥檚 initial recommendations. In contrast, the Society of Obstetricians and Gynaecologists of Canada (SOGC) and other in maternal health recommended that pregnant people were offered the vaccines from the outset.
As more information became available demonstrating the safety of vaccination in pregnancy, these guidelines have been updated and are now more closely aligned.
Clinical trials on mRNA vaccination in pregnancy are underway, including at the U.S. and ). AstraZeneca and had planned clinical trials in pregnancy, . It will be several months before any trial data become available, long after most Canadians will have made their decisions about COVID-19 vaccination.
The highest quality evidence should have been available to inform vaccine policies, recommendations and individuals鈥� 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 in the United States. Most received Pfizer/BioNTech or Moderna mRNA vaccines. have been published, showing no safety concerns so far.
Recent studies also suggest that after vaccination, COVID-19 antibodies and also and may protect the infant.
For pregnant or breastfeeding people seeking information, SOGC offers answers to COVID-19 vaccine , a detailed and other resources. Local and and have also developed information to help pregnant or breastfeeding individuals make informed decisions about COVID-19 vaccination.
Long-term followup
There is a need for long-term followup of people vaccinated in early stages of pregnancy and their infants. Public Health and researchers in Canada continue to monitor pregnant individuals who have received a COVID-19 vaccine. Pregnant and breastfeeding individuals can sign up to participate in these programs: and the .
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.
鲍鱼tv are women, many of whom are of reproductive age. In Canada, among nurse aides, orderlies and patient service associates who may be prioritized for vaccination.
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.
Do you have a question about COVID-19 vaccines? Email us at 肠补鈥惫补肠肠颈苍补迟颈辞苍蔼迟丑别肠辞苍惫别谤蝉补迟颈辞苍.肠辞尘 and vaccine experts will answer questions in upcoming articles.
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