Freedom of Information request on monitoring reports of adverse drug reactions in pregnant women following COVID-19 vaccination (FOI 21/863)
Published 25 February 2022
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9th September 2021
FOI 21/863
Dear
Thank you for your correspondence of the 29th July 2021 regarding spontaneous abortion following to COVID-19 vaccination.
We have been closely monitoring reports of adverse drug reactions in pregnant women following COVID-19 vaccination and have recently published an update in our weekly summary of Yellow Card reporting Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk).
In summary, the numbers of reports of miscarriage following COVID-19 vaccination are low in relation to the number of pregnant women who have received these vaccines to date (more than 65,000) and how commonly these events occur in the UK outside of the pandemic. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage or stillbirth. Sadly, miscarriage is estimated to occur in about 20 to 25 in 100 pregnancies in the UK and most occur in the first 12 to 13 weeks of pregnancy (the first trimester).
Should safety concerns be identified, these would be documented and taken to the Vaccine Benefit-Risk Expert Advisory Group for independent advice. Internal comments on individual cases and case series as requested fall under Section 35 of the Freedom of Information Act (formation of future policy) and as such this information cannot be released.
The MHRA will continue to closely monitor safety data for use of the COVID-19 vaccines in pregnancy.
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division