Freedom of Information request on the safety and efficacy of COVID-19 vaccines (FOI 22/550)
Published 14 June 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-25-april-2022/freedom-of-information-request-on-the-safety-and-efficacy-of-covid-19-vaccines-foi-22550
FOI 22/550
26th April 2022
Dear
Thank you for your email and we apologise for delay in response.
The MHRA continually monitors safety during widespread use of a vaccine. We have in place a proactive strategy to do this which has been published online: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance. Part of our monitoring role includes reviewing reports of suspected side effects, and the MHRA publishes a report summarising the suspected adverse reactions reported via the Yellow Card scheme: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects, as well as other academic and international data relating to this. It is this multitude of data on the effectiveness of the COVID-19 vaccines which Dr Alison Cave has referred to in this statement. This comes from published data in both peer review journals, several examples of which can be found here: https://www.gov.uk/guidance/monitoring-reports-of-the-effectiveness-of-covid-19-vaccination as well as the regular monitoring reports published by the UK Health Security Agency (UKHSA) the most recent of which can be found here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1067158/vaccine-surveillance-report-week-14.pdf
Please be assured that the MHRA keeps the safety and effectiveness of the COVID-19 vaccines under close and continual review.
The authorisation of the Pfizer/BioNTech, AstraZeneca and Moderna vaccines under Regulation 174 in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
In addition, a marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). Further information is available on the MHRA website and the EMA website, links to 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
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen
A marketing authorisation has been granted for the Nuvaxovid vaccine on 03 February 2022. Further information is available via the below link:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid
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
Yours sincerely
MHRA Customer Experience Centre