FOI release

Freedom of Information request on COVID-19 vaccination in pregnancy (FOI 21/840)

Published 20 January 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-16-august-2021/freedom-of-information-request-on-covid-19-vaccination-in-pregnancy-foi-21840

20th August 2021

FOI 21/840

Dear

Thank you for your FOI request dated 22nd July 2021. Please find below the answers to your questions:

  • Does the MHRA know how many pregnant women received a coronavirus vaccine in the period December 9th 2020 and March 7th 2021?

Information for that precise timeframe is not currently available. Data from Public Health Scotland (see https://publichealthscotland.scot/publications/covid-19-statistical-report/covid-19-statistical-report-14-july-2021/, show that 733 pregnant women in Scotland were vaccinated up to end February 2021. Data from Public Health England show that 51,724 pregnant women in England had received at least one dose up to 18 July.

  • Was data gathered on the numbers of women who accidentally had the vaccine while pregnant in the period December 9th 2020 and March 7th 2021, for example via the yellow card reporting system, the inadvertent vaccination in pregnancy system, or another method? If not, why was this data not gathered?

Public Health England have been gathering information on women who realised that they were pregnant after they received the vaccine via the inadvertent vaccination in pregnancy system.

  • Does the MHRA have revised estimate figures on the likely number of women who were pregnant and received the vaccine in the time period December 9th 2020 and March 7th 2021? See question 1 above.

  • When that fact check statement was given to Reuters, did anyone record or make note of the fact that the figures being given were likely inaccurate? Did any discussion of this happen or get recorded?

The figures provided for the Reuters fact check query in March were not inaccurate and the text made it clear that these were an estimate of the numbers of women in the relevant age group. Information on the number of pregnant women who had received a coronavirus vaccine was not available at that time. Consequently the numbers of women of child bearing age were provided to give context to the increased numbers of miscarriages that had been reported in the time frame.

  • In the statement, the MHRA noted that they were closely following reports of an increased risk of miscarriage when pregnant women receive the vaccine before week 12 of pregnancy. Have these reports continued? Does the MHRA have any records and/or analysis of these reports? If so, where can they be accessed? If not, why not?

The statement ‘they were closely following reports of an increased risk of miscarriage when pregnant women’ does not accurately reflect the Reuter’s post. To clarify, the Reuter’s post stated ‘The MHRA added that it was closely monitoring a small number of miscarriage reports following vaccine exposure in the first 12 weeks of pregnancy, but said there was “no pattern” to suggest an increased risk.’

Reports of miscarriage received have been published in the weekly COVID-19 vaccine analysis prints on the MHRA website (see Coronavirus (COVID-19) vaccine adverse reactions - GOV.UK (www.gov.uk)). Reviews of these reports have been considered by the independent experts of the Commission on Human Medicines’ COVID-19 Vaccines Benefit Risk Expert Working Group and by the Medicines for Women’s Health Expert Advisory Group (MWHEAG) who concluded that there is currently no evidence 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. Further information on this is included on the MHRA website:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#contents

The MHRA continues to closely monitor safety data for use of the COVID-19 vaccines in pregnancy.

  • Are there any plans to revise the comments given in the linked fact check in order to more accurately relay the true context of how many pregnant women would have been likely to have received the vaccine in that time period?

The information provided for the earlier fact check was accurate for the information available at that time and remains true even if based only on the additional information on the number of women exposed in pregnancy in Scotland for that time period.

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

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