Freedom of Information request for the safety data submitted to the MHRA in respect of the Regulation 174 authorization of the COVID-19 Vaccine AstraZeneca/COVID-19 Vaccine (FOI 21/445)
Published 28 June 2021
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26th May 2021 FOI 21/445 Dear
Thank you for your email dated 26th April where you asked: “Please provide me with complete safety data submitted to the MHRA in respect of the regulation 174 authorization of the COVID-19 Vaccine AstraZeneca/COVID-19 Vaccine (ChAdOx1 S [recombinant]) between 24/09/2020 to 29/12/2020.”
Regarding your request for the “safety data submitted to the MHRA in respect of the Regulation 174 authorization of the COVID-19 Vaccine AstraZeneca/COVID-19 Vaccine (ChAdOx1 S [recombinant]) between 24/09/2020 to 29/12/2020”, MHRA is withholding the information requested 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 overriding argument for releasing the information that outweighs the commercial harm by providing potential competitors with information about the product development and study designs used to gain authorisation under Regulation 174.
Notwithstanding the above paragraphs, safety data are published within the Public Assessment Reports [PARs] which are referenced below.
The temporary authorisations for use of the COVID-19 vaccines 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 non-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 Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Link to this is provided below: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
In addition, the European Commission, following recommendations from the European Medicines Agency (EMA), have granted a marketing authorisation for the Oxford/AstraZeneca vaccine. Further information is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
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: info@mhra.gov.uk
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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