Freedom of Information request about the safety of COVID-19 vaccines (FOI-21-124)
Published 28 April 2021
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Thank you for your email dated 2nd February.
As part of the application for authorisation for use, a Risk Management Plan (RMP) and a summary of the pharmacovigilance system for the safe use of COVID-19 vaccines were provided and assessed by the MHRA, and agreed to be satisfactory. A description of the RMP, including details of the Pharmacovigilance Plan, can be found in the Public Assessment Reports for the vaccines:
Pfizer/ BioNTech https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19.
AstraZeneca https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
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
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,
FOI Team Vigilance and Risk Management of Medicines Division