FOI release

Freedom of Information request (FOI 22/953)

Published 17 January 2024

FOI 22/953

16th September 2022

Dear

Thank you for your email.

A marketing authorisation for the Spikevax bivalent Original/Omicron vaccine (PLGB 53720/0004) was granted on 12 August 2022. Further information is available via the following link:

https://www.gov.uk/government/publications/regulatory-approval-of-spikevax-bivalent-originalomicron-booster-vaccine  

A marketing authorisation for the Comirnaty Original/Omicron vaccine (PLGB 53632/0010) was granted on 02 September 2022. Further information is available via the following link:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizerbiontech-bivalent-originalomicron-booster-vaccine

As we plan to publish the Public Assessment reports in the next 8 weeks, we consider that your request is covered by section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. 

Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it.  We recognise there is strong interest in seeing this data and accept it should not be withheld. We believe that the public interest will be best served by accompanying the publication of the data with an analysis to aid its interpretation which is currently under preparation

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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

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