Freedom of Information request on the authorisation of COVID-19 vaccine Vaxzevria (FOI 21/1039)
Published 25 February 2022
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22nd September 2021
FOI 21/1039
Dear
Thank you for your email.
The details for the authorisation of Vaxzevria (the AstraZeneca vaccine) are published on the MHRA website. This includes MHRA’s assessment of vaccine, which is included in the Public Assessment Report (PAR). A PAR is also published by the European Medicines Agency (EMA). Links to both of these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
MHRA cannot comment on the assessment of CoviShield and the release of any information MHRA holds on this would be exempt under Section 41 (Information provided in confidence) and Section 43 (Commercial interests). 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 any further information on a medicine that has not been approved to be an actionable breach of confidence. Section 43 is a conditional 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 harm in releasing any information we hold on medicines that have not yet been approved. Such information can be used by competitors for their commercial advantage.
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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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