FOI release

Freedom of Information request (FOI 22/1180)

Published 17 January 2024

FOI 22/1180

18th December 2022

Dear

Thank you for your email.

Additional information concerning the authorisation of the Pfizer/BioNTech vaccine Comirnaty for infants and children aged 6 month to 4 years is available below:

https://www.gov.uk/government/news/pfizerbiontech-covid-19-vaccine-authorised-for-use-in-infants-and-children-aged-6-months-to-4-years

A Public Assessment Report (PAR) will be published by MHRA in the next 60 calendar days.

A PAR has been published by the EMA and is available through the below link:

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

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