Freedom of Information request (FOI 22/1186)
Published 17 January 2024
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FOI 22/1186
28th December 2022
Dear
Thank you for your information request dated 11 December 2022 where you asked for the following information:
“Please provide all the raw data/information that the MHRA relied upon in order to approve the Pfizer covid vaccine for use in children 6 months to 4 years old. This should include all publicly available data and information and all available information and data not in the public domain.”
We are pleased to provide you with the information requested, see below.
The raw clinical data is available from the EMA Clinical Data Repository. A link to this is provided below:
https://clinicaldata.ema.europa.eu/web/cdp/home
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 Service Centre