FOI release

Freedom of Information request on the approval of the Pfizer COVID-19 vaccine (FOI 22/674)

Published 22 March 2023

FOI 22/674

30 May 2022

Dear,

Thank you for following-up in relation to the scope your client’s request, as per your email of 10 May 2022.

If we were to process this request in its present state under FOIA, unfortunately, we would need to refuse it under Section 12 or 14.

Section 12 applies when the cost exceeds then limit of 24 hours to determine if the information is held, locate, retrieve, and extract the information.

A Section 14. refusal, can be used in situations where handling multiple requests or a single request, would lead to a grossly excessive burden being placed on the public body or institution. We expect that this burden would be incurred due to the need to read, consider, and apply redactions, to the vast array of regulatory material encompassed by the request.

However, in line with the ICO advice related to advice and assistance. We would like to suggest that your client considers an early refinement of their request before a formal refusal notice is issued. We do not wish to steer your client in a specific direction with regards to refinement, as this could be mis-interpreted. Therefore, we instead propose that your client reviews the public assessment reports (see, correspondence on 5 May 2022) and selects a certain study or concept which they find of particular interest. Then should they wish to, your client/s can lodge a refined request or requests.

Please note, that MHRA have been experiencing a busy period during the pandemic.  Obtaining a response prior to submitting a new request will help alleviate additional pressure on resources.

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