FOI release

Freedom of Information request on a COVID-19 vaccine (FOI 20-569)

Published 24 March 2021

Thank you for your email of 11 December 2020, where you have asked “Under the freedom of information act please can you provide me with all the details and information you hold that was used to determine how the Pfizer covid 19 vaccine was safe and effective to be used and granted a licence to be used in an emergency.if this was decided by a vote please provide the names who voted and how they voted”

Information on the studies conducted using the Pfizer/BioNTech COVID-19 vaccine and their results are available in a peer-reviewed journal, the New England Journal of Medicine. A link to this is provided below: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

The approval for use of the Pfizer/BioNTech COVID-19 vaccine in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech COVID-19 vaccine, a Public Assessment Report (PAR) has been published, which consists of the non-confidential aspects of the MHRA’s assessment of this vaccine. A link to the MHRA PAR is provided below: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

With regards to your query concerning whether any vote took place at CHM, the opinions on individual CHM members is exempt under S40 (Personal information) that protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information and Section 38 (Health and safety) of the FOIA where the information is withheld because we consider that its disclosure would, or would be likely to endanger the physical or mental health, or the safety, of any individual. Section 38 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. We have considered the public interest and cannot see any public interest argument that outweighs the harm in providing details of the opinions of individual CHM members. To release such information would expose CHM members to probable harassment by individuals and organisations who dispute individual members opinions. Further, to release this information would stifle the free and frank discussions amongst CHM members.

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

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000