Freedom of Information request on the UK Risk Management Plans for each of the three COVID-19 vaccines (FOI 21/949)
Published 17 January 2022
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16th September 2021
FOI 21/949
Dear
Thank you for your information request, dated 18 August 2021, where you asked for ‘a copy of the population level surveillance data from April 2021 onwards which you are using to monitor the risk of Vaccine Associated Enhanced Disease’. In a further email dated 19 August 2021 you clarified your request as follows: “To clarify, I am requesting the data you have collected relating to MHRA’s surveillance of the VAED risk with the three Covid vaccines above. My understanding is that, in following the EMA’s RMP, you will be comparing data from the ongoing controlled clinical trials investigating VAED risk (vaccinated vs placebo) against potential signs of VAED from the roll-out to the UK population (Covid infection post-vaccination vs unvaccinated ). I would think that those data will include things like comparative rates of death and hospitalisation, rate of clinical deterioration, length of clinical course, complications and new morbidities, and stratified by factors like time since vaccination, age, gender and prior co-morbidities. For further clarity, I am not interested in individual patient data, just summary numbers/data.”
I can confirm that we do not hold the information you have requested. You are correct in that the UK Risk Management Plans for each of the three COVID-19 vaccines currently used in the UK (Pfizer/BioNTech; AstraZeneca and Moderna vaccines) are the same as the European Medicines Agency’s RMPs for these vaccines. However, please note that the requirements in the RMP are binding on the marketing authorisation holders and not on regulatory authorities such as MHRA. Furthermore, these studies are ongoing and to date the interim reports submitted to MHRA by the marketing authorisation holders have not included any data or analyses on VAED.
Public Health England (PHE) are also closely monitoring vaccine effectiveness and we are working closely with PHE to monitor the impact of the COVID-19 vaccination programme.
If you have any queries, please reply to this email.
Kind regards,
FOI Team Vigilance and Risk Management of Medicines Division