Freedom of Information request to Medicines and Healthcare products Regulatory Agency (FOI-20-566)
Published 24 March 2021
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Thank you for your email.
Information on the clinical study performed for the authorisation of the Pfizer/BioNTech vaccine is available in the Public Assessment Report (PAR) and the peer-reviewed article by the New England Journal of Medicine (NEJM). Both are accessible via the links below:
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19
Any further 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 would consider the release of this information to be an actionable breach of confidence. Section 43 is a qualified exemption and requires a consideration of the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the harm that can be done by providing information concerning a medicine that has not been granted a marketing authorisation (the Pfizer/BioNTech vaccine has been authorised for use under Regulation 174), which can be used by competitors for their commercial gain.
Kind Regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
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Telephone 0203 080 6000