Freedom of Information request about study data for the Pfizer/BioNTech vaccine (FOI-21-340)
Published 28 May 2021
© Crown copyright 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-12-april-2021/freedom-of-information-request-about-study-data-for-the-pfizerbiontech-vaccine-foi-21-340
Regarding your request for the study data for the Pfizer/BioNTech vaccine that was submitted to MHRA, this information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.
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 commercial harm in providing information that can be used by competitors for their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.
The MHRA’s assessment of the data submitted for the Pfizer/BioNTech vaccine is published in the Public Assessment Report (PAR) for this vaccine, which has been sent to you in a previous response.
For your further information, this vaccine, with a product name of Comirnaty, was approved by the European Medicines Agency (EMA) in December 2020, when the UK was still in the transition period, in relation to leaving the European Union. During the transition period, any medicine licensed by the EMA automatically became licensed in the UK at the same time: thus, from December 2020, this vaccine has been licensed in the UK.
There is also public information on the approval of Comirnaty at this link, where the European Public Assessment Report (EPAR) can be found: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty.
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
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: [email protected]
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
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000