FOI release

Freedom of Information request for the latest version of MHRA "Risk v Benefit analysis" for Covid 19 AstraZeneca / Oxford vaccine, and Covid 19 Pfizer / BioNTech vaccine (FOI 21-347)

Published 28 June 2021

5th May 2021 FOI 21/347

Thank you for your email dated 3rd April 2021, where you asked:

“Following the decision by Germany and Netherlands to restrict the use of the Covid 19 AstraZeneca vaccine in people under 60 years of age due to blood clotting concerns I would be pleased to receive the following information under the F O I Act 2000.

  1. Copy of the latest version of MHRA “Risk v Benefit analysis” for Covid 19 AstraZeneca / Oxford vaccine, and

  2. Copy of the latest version of MHRA “Risk v Benefit analysis” for Covid 19 Pfizer / BioNTech vaccine.”

In answer to your request, we would like to direct you to the weekly published summary of Yellow Card reporting for COVID-19 vaccines. This report summarises information received via the Yellow Card scheme and is updated regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

You may also wish to read the latest statement from the JCVI on the use of the AstraZeneca COVID-19 vaccine: https://www.gov.uk/government/news/new-jcvi-advice-on-use-of-the-astrazeneca-covid-19-vaccine

I hope the information provided is helpful, but 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 of this response; and can be addressed to this email address.

Yours sincerely, FOI Team Vigilance and Risk Management of Medicines Division