Freedom of Information request on the safety of COVID-19 vaccines and pregnancies (FOI 21/1250)
Published 31 May 2022
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FOI 21/1250
7th December 2021
Dear,
Thank you for your email.
The safety of COVID-19 vaccines in pregnancy has been monitored closely throughout the vaccination programme. The latest information on this can be found on the MHRA website: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. This has built on information from non-clinical data which did not raise any safety concerns and confirmed that the COVID-19 vaccines do not contain organisms that can multiply in the body, so they cannot infect an unborn baby in the womb.
There are two company sponsored international trials of COVID-19 vaccines in pregnancy underway: one for COVID-19 Pfizer/BioNTech Vaccine (in UK and other countries) and one for COVID-19 Janssen Vaccine (mainly in USA and Brazil). There are also government sponsored trials underway led by academic researchers, such as the Preg Cov trial in the UK. Information relating to these trials is available publicly here; https://clinicaltrials.gov/ct2/show/NCT04754594, https://clinicaltrials.gov/ct2/show/NCT04765384, https://www.gov.uk/government/news/new-study-into-covid-19-vaccine-dose-interval-for-pregnant-women
In addition there are a number of observational studies in the UK and elsewhere around the world looking at COVID-19 vaccine effects in pregnancy.
The summary meeting minutes from the CHM are available on the MHRA website: https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership#summary-minutes
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Yours sincerely,
MHRA Customer Service Centre