Freedom of Information request on the benefit and risk balance on the COVID-19 vaccines (FOI 21/959)
Published 25 February 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-6-september-2021/freedom-of-information-request-on-the-benefit-and-risk-balance-on-the-covid-19-vaccines-foi-21959
7th September 2021
FOI 21/959
Dear
Following review of available evidence on quality, safety and efficacy, the MHRA, with advice from the government’s independent expert scientific advisory body (the Commission on Human Medicines), has concluded that the benefits of the COVID-19 vaccines Pfizer BioNTech, AstraZeneca, Moderna and Janssen are greater than the risks and recommended that the vaccines could be authorised for active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus. We have previously provided links to the public assessment reports which contain details of the MHRA and European Medicines Agency’s evaluation of these vaccines.
The main efficacy and safety results for the Phase I, II and III trials for all authorised vaccines have been submitted to MHRA, sufficient that these vaccines can be authorised for use in the patient populations stated in the Information for Healthcare Professionals/Summary of Product Characteristics for each vaccine. These studies are currently ongoing to follow-up vaccine recipients to collect additional safety data, in the same way that all clinical trials for new medicines follow up their study subjects after the main results of the study have been reported. Other studies that are currently in progress are either for cohorts/subpopulations of recipients or to investigate different regimens (such as giving different brands of vaccine for the first and second doses).
Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination, and the MHRA has a proactive strategy for vaccine safety surveillance to monitor for and evaluate emerging safety concerns following COVID-19 vaccination which can be found here https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance
The information for healthcare professionals and UK recipients on using the COVID-19 vaccine safely is provided on the MHRA website has been periodically updated as new data have become available:
In addition the MHRA regularly publishes reports of the safety of the COVID-19 vaccines and other updates about our work on Covid-19 vaccines. This information can be found at:
https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19
As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.
Kind regards,
MHRA Customer Service Centre