FOI release

Freedom of Information request (FOI 22/911)

Published 17 January 2024

FOI 22/911

30th September 2022

Dear

Thank you for your request on 17th August 2022 where you requested the following:

Please provide all information that you hold, from July 1, 2020 until today, for the following:

  • any MHRA evaluation of Moderna (Spikevax) and/or Pfizer (Comirnaty) vaccines for children under 5 years of age?

  • any applications made to permit the use of Moderna (Spikevax) and/or Pfizer (Comirnaty) vaccines in children under 5 years of age?

By “all information”, this should include, but not be limited to emails (and their attachments); letters; briefings; memos; reports; press enquiries and their responses; newspaper cuttings; news web links; and any notes taken during telephone conversations

We can neither confirm nor deny that we hold information falling within the scope of your request. The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act. This should not be taken as an indication that the information you requested is or is not held by the department.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the potential commercial harm for relevant companies.

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

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

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

We appreciate that this news may be disappointing, but when viewed against the context of the volume of requests that you have made to MHRA we feel that this has been a necessary step to help preserve our administrative and technical resource.

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 FOI Team