Freedom of Information request on the temporary authorisations for use of the COVID-19 vaccines in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness (FOI 21/874)
Published 27 April 2022
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9th August 2021 FOI 21/874
Dear
Thank you for your email.
The temporary authorisations for use of the COVID-19 vaccines 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-pfizer-biontech-vaccine-for-covid-19 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
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
In addition, the European Commission, following recommendations from the European Medicines Agency (EMA), have granted a marketing authorisation for the Oxford/AstraZeneca vaccine. Further information is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
The only questions that we can provide a response to is as below. The other questions we confirm we do not hold this information: - How many Covid19 vaccines are only authorised or approved for emergency use within the UK? If so, which vaccine? No Covid-19 vaccine is only authorised for emergency use in the UK.
- How many Covid19 vaccines are fully authorised or approved for use within the UK for the UK? If so, which vaccine? All Covid-19 vaccines that have been authorised have marketing authorisations in the UK.
Death statistics are not held by the MHRA and as such we would advise you to contact the Office for National Statistics Contact us - Office for National Statistics (ons.gov.uk)
The Yellow Card scheme is run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. Reports received through our Yellow Card scheme include some fatality reports and these can be viewed by following the link below: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
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
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
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 Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU