FOI release

Freedom of Information request on the regulatory approval of the COVID-19 Pfizer vaccine (FOI 21/1241)

Published 31 May 2022

© Crown copyright 2022

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-6-december-2021/freedom-of-information-request-on-the-regulatory-approval-of-the-covid-19-pfizer-vaccine-foi-211241--2

FOI 21/1241

6th December 2021

Dear

Thank you for your communication to the MHRA in relation to a Freedom of Information request for:

  1. Is the MHRA aware of the whistleblower report published  in the British Medical Journal?

  2. What steps are being taken by the MHRA to investigate the malpractice claims made by the report, specifically in relation to trial data falsification?

  3. Will MHRA revoke the regulatory approval of the Pfizer Covid-19 vaccine if the claims are correct? If not, explain why not.

On the basis of extensive data we know that the Pfizer/BioNTech COVID-19 vaccine is safe and effective. People should continue to get vaccinated to protect themselves and others.

We take allegations of any regulatory misconduct seriously. Our investigations have now concluded and found that there was no impact on the data reliability.

If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.gov.uk

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

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

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

IE&S FOI Team

Back to top