Freedom of Information request on the safety of COVID-19 vaccinations and pregnant women (FOI 22/639)
Published 21 December 2023
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FOI 22/639
20th July 2022
Dear
Thank you for your email, please accept our apologies for the delay in responding.
There is no single date (or set of dates) when each vaccine was designated to be safe in pregnancy. The safety of COVID-19 vaccines in pregnancy has been monitored closely by MHRA throughout the vaccination programme and evidence has accumulated through clinical use in the UK and elsewhere. This has built on information from non-clinical data considered at the time of authorisation of the COVID-19 vaccines 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. Extensive post-marketing experience of the use of the Pfizer BioNTech and Moderna (mRNA) vaccines against COVID-19 in the USA raised no safety concerns regarding their use in pregnancy. These data have been published in the medical literature. Experience with COVID-19 vaccines in the UK, through Yellow Card reports and public health surveillance through UK Health Security Agency (UKHSA, formerly Public Health England) and Public Health Scotland, has been consistent with these data.
In April 2021, the Joint Committee on Vaccination and Immunisation (JCVI) considered that the benefits outweighed risks in pregnancy and advised that pregnant women should be offered the COVID-19 vaccine at the same time as their clinical risk or age groups. On 16th December 2021, the JCVI updated their advice to recommend use in pregnancy, since pregnancy itself is now recognised as a clinical risk condition for COVID-19 infections. Accordingly the JCVI placed pregnant women on the priority list for vaccinations against COVID-19.
The latest information on safety of the COVID-9 vaccines in pregnancy can be found on the MHRA website: Coronavirus vaccine - summary of Yellow Card reporting - GOV.UK (www.gov.uk)
I hope this information is helpful. Please be assured that the MHRA continues to closely monitor any emerging information on the safety of COVID-19 vaccines in pregnancy.
If you have a query about the information provided, please reply to this email.
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Yours sincerely
MHRA Customer Experience Centre