FOI release

MHRA Agreement on 12-Week Pfizer COVID-19 Vaccine Dosing Interva

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00807

Received 22 July 2026

Published 9 September 2026

Request

Thank you for acknowledging my request under reference FOI2026/00804. I am writing promptly because the scope reproduced in your acknowledgement differs materially from the request I submitted. To avoid unnecessary searches and any risk of exceeding the cost limit, please treat the following as a clarification of the original request, not as a new or expanded request. The relevant date range is: 25 December 2020 to 10 January 2021 inclusive. I request only recorded information documenting the nature, scope, or form of the "MHRA agreement" referred to in the UK COVID-19 Technical Report, Chapter 9, in connection with the JCVI recommendation that the interval between doses of BNT162b2 could extend to 12 weeks. Specifically, I request: 1. Any formal agreement, memorandum, written confirmation, decision record, or meeting record provided by or recording the position of MHRA concerning the acceptability of a programme interval of up to 12 weeks for BNT162b2. 2. Any record explaining whether the wording "at least 21 days" in MHRA's updated advice and applicable product information was understood by MHRA as permitting a programme interval of up to 12 weeks, or whether it stated only a minimum interval without affirmatively endorsing that particular upper interval. For the avoidance of doubt: - I am not requesting general correspondence with Pfizer/BioNTech. - I am not requesting all communications concerning dose spacing. - I am not requesting a general search for legal opinions. - I am not asking about a Conditional Marketing Authorization unless a record within the narrow scope above specifically relies on one. - Duplicate records, routine administrative correspondence, and press-monitoring material remain excluded. Please confirm that the request will be processed using this clarified scope. If any further refinement would assist disclosure under section 16 of the Freedom of Information Act 2000, I would be happy to discuss it.

Response

See attached

Documents

• FOI2026_00807 (redacted).pdf (1.2 MB)

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