FOI release

Freedom of Information request on changes to menstruation following COVID-19 vaccination (FOI 21/693)

Published 29 December 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-july-2021/freedom-of-information-request-on-changes-to-menstruation-following-covid-19-vaccination-foi-21693

21st July 2021

FOI 21/693

Dear

Thank you for your information request, dated 21 June 2021, where you asked for:

On 20th June 2021, the Sunday Times reported that almost 4,000 women have reported “period problems after having their Covid jab” to yourselves. The article goes on to say, “Asked why the problems had not been added to the official list of possible side effects of the Covid-19 vaccines, the MHRA said a review with experts had found that there was no need to do so”.

  1. Please provide the names of the “experts” that the MHRA consulted about this, and the organisations that they work for.

  2. Please provide dates and reason for payment of all/any sums of money paid by the MHRA to, or received by the MHRA from, these persons and organisations over the last 10 years.

  3. Please provide a copy of said review, and any notes, memos and correspondence related to it, including (but not limited to) discussions about including or not including these problems in the official figures, and the reasons for finally deciding that they should not be included. This includes copies of any audio or video recordings of meetings about this matter, as well as paperwork.

I am pleased to provide you with some of the information requested, see below.

Question 1

The MHRA is investigating reports of menstrual disorders (period problems) and unexpected vaginal bleeding following vaccination against COVID-19 in the UK. These reports are also being reviewed by the independent experts of the Commission on Human Medicines’ COVID-19 Vaccines Benefit Risk Expert Working Group and members of the Medicines for Women’s Health Expert Advisory Group.

Membership of the Commission on Human Medicines (CHM) and its expert advisory groups (EAGs), including membership of the COVID-19 Vaccines Benefit Risk Expert Working Group and the Medicines for Women’s Heath EAG and the organisations they work for, are available at: https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership.

Question 2

Members of the CHM and its EAGs receive an attendance fee and payment for expenses where necessary. Please see under ‘Working for us’ in the following link: https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership)).

Question 3

The information requested is currently exempt from release under:

Section 35 - Formulation of Government policy: the information you have requested is being withheld under section 35 of the FOI Act. We are withholding this information because the review of the menstrual disorders (period problems) and unexpected vaginal bleeding following vaccination against COVID-19 in the UK is ongoing and decisions have not yet been made. Section 35 protects the internal deliberative process as it relates to Government policy making. In other words, the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions.

However, you may be interested to know that the MHRA publishes a coronavirus vaccine weekly summary of Yellow Card reporting which includes information on our analysis of data and comments on specific reports including reports of menstrual disorders and unexpected vaginal bleeding. This report is updated weekly and available at: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. As outlined in this report, the MHRA is carrying out a detailed analysis of the evidence for review by experts.

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.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

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