FOI release

Freedom of Information request on the adverse events following Pfizer vaccinations (FOI 22/717)

Published 21 December 2023

FOI 22/717

22nd July 2022

Dear

Thank you for your email of 21 May 2022. Apologies for the delay in responding to you.

Please find below answers to the questions you have raised below:

Firstly, we can only answer from the MHRA’s perspective. The Joint Committee on Vaccination and Immunisation (JCVI) is a separate organisation.

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this and we also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.

Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated (over 148 million COVID-19 vaccines have been given in the UK alone to date), including elderly people and people who have underlying illness.

The specific document you refer to has not been submitted to the MHRA. However, the MHRA regularly review safety information from the COVID-19 vaccine manufacturers and are in regular contact with other regulators across the world to exchange safety data on the COVID-19 vaccines. This information is considered in our assessments alongside the UK data, to ensure that the balance of benefits and risks of the COVID-19 vaccines remains favourable. The Pfizer document you refer to contains global safety data in relation to Pfizer’s COVID-19 vaccine, including post marketing reports of suspected ADRs from the UK. The MHRA will also have all the UK reports mentioned in the document on their safety database, along with the serious reports from other countries.

The Pfizer vaccine was authorised in the UK in December 2020, on the basis of a review of data provided by the company on quality, safety and efficacy. This was prior to the release of the Pfizer report you mention, which contains information from the post authorisation period. The JCVI also made the recommendation to roll the Pfizer vaccine out in the UK prior to the date of the aforementioned report.

The MHRA publishes listings of suspected adverse reactions to the COVID-19 vaccines along with information about our analysis of safety data regarding COVID-19 vaccines in our weekly summary of COVID-19 vaccine Yellow Card reports which is available at: Coronavirus vaccine - summary of Yellow Card reporting - GOV.UK (www.gov.uk)

Please be assured that the MHRA continues to closely monitor the safety of the COVID-19 vaccines used in the UK.

I hope this information is helpful.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre