Freedom of Information request on authorisation of COVID-19 vaccinations (FOI 21/913)
Published 20 January 2022
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23rd August 2021
FOI 21/913
Dear
Thank you for your email of 09 August 2021.
The temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation.
All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective Covid-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a Covid-19 vaccine. No stages in the vaccine development processes were bypassed.
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, Moderna 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
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, 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
As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.
No medicine is 100% safe. However, the data collected from the clinical studies performed for each of the authorised vaccines do not show the spike proteins having any harmful effect on the human body. The MHRA’s and the EMA’s assessment of each of the authorised vaccines, including the clinical assessment of each vaccine, is available in the PARs that we have provided the links for above.
We hope you find this information useful. If you require any further information please let us know.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.
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Yours sincerely
MHRA Customer Service Centre