Freedom of Information request on the authorisation documents for the COVID-19 Pfizer vaccination (FOI 22/756)
Published 4 January 2024
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FOI 22/756
28th July 2022
Dear
Thank you for your information request dated 13 June 2022 where you refined your information request:
Our Initial Request
All documents the MHRA relied upon to approve the use of Pfizer’s COVID-19 vaccine and/or Comirnaty.
Our Refined Request
- Any document that references Subject ID number: 12312982
- The full ingredient list of the vaccine
- All documents concerning site number 1085 (Ventavia Research Group)
- The dataset for ADC19EF
- All Reports of Efficacy and Safety Studies
- All Reports of Postmarketing Experience
- All periodic safety reports submitted by the sponsor to the MHRA
- All documents concerning Important Protocol Deviations (IPDs)
The data for the initial marketing authorisation of the Pfizer vaccine (Comirnaty) are available through the European Medicines Agency (EMA). A link is provided below:
https://clinicaldata.ema.europa.eu/web/cdp/home
Further, the non-confidential parts of the MHRA assessment reports are published in the Public Assessment Reports (PARs) that are available on the MHRA and EMA websites. Links to these for Comirnaty are provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
The full ingredient list for Comirnaty is available through the SmPCs that are published on the MHRA website. A link to this is provided below:
https://products.mhra.gov.uk/search/?search=comirnaty&page=1
All protocol deviations that occurred during the clinical studies conducted are reported in the clinical study reports for this product. These are available via the EMA published clinical data, which we have provided the link for above.
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.
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
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