FOI release

Freedom of Information request on the regulatory approval of the COVID-19 AstraZeneca vaccine (FOI 22/453)

Published 31 May 2022

FOI 22/453

17th February 2022

Dear

Thank you for your email.

The decision to grant a marketing authorisation for the AstraZeneca vaccine was not made by any director at MHRA, nor do they play any part in the decision making regarding the authorisation of specific vaccines.

In your request you state that two MHRA directors are AstraZeneca shareholders. I understand you are referring to two of the MHRA’s Non-Executive Directors who sit on the MHRA Board, whose declarations of interest are published on GOV.UK. I can confirm that one of the MHRA’s current Non-Executive Directors declared shareholdings with AstraZeneca; and another Non-Executive Director who departed from the MHRA Board in August 2021 also declared shareholdings with AstraZeneca. I can confirm that neither of these Non-Executive Directors had any involvement in the approval of the AstraZeneca Covid-19 vaccine. The Board has no involvement in any regulatory decisions affecting medicines, medical devices or any other products or services delivered by the Agency. These are the responsibility of the Chief Executive Officer, supported by the Executive Committee. MHRA Staff members can not hold direct financial interests in the pharmaceutical and healthcare (medical devices) industries.

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