Freedom of Information request about COVID-19 vaccine safety analysis (FOI-21-175)
Published 7 May 2021
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Our Ref: FOI 21/175 Dear Thank you for your email dated 11th February 2021, where you asked: “How do MHRA safety analyses of the COVID vaccines differ from MHRA safety analyses of the Pandemrix vaccine” One of MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use. Every vaccine requires a tailored vigilance strategy and we have in place a proactive strategy to do this for COVID-19 vaccines. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals. The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the reaction. All reports from the UK vaccination campaign undergo robust scientific evaluation by the MHRA alongside data available from international sources. This is further considered by the Commission on Human Medicine and its Expert Advisory Groups. Yellow Card data cannot be used to derive side effect rates or compare the safety profile of different vaccinations as many factors can influence ADR reporting. 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