Freedom of Information request on a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) - (FOI 22/395)
Published 31 May 2022
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FOI 22/395
4th February 2022
Dear,
Thank you for your email.
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
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
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
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 to investigate the use of vaccine outside of the current authorisations (such as giving different brands of vaccine for the first and second doses).
The estimated dates for the end of completion of the clinical trials are as follows:
AstraZeneca Phase I/II Estimated Study Completion Date: November 15, 2021 https://clinicaltrials.gov/ct2/show/NCT04568031
AstraZeneca Phase III Estimated Study Completion Date: February 14, 2023 https://clinicaltrials.gov/ct2/show/NCT04516746
Pfizer/BioNTech PHASE 1/2/3, Estimated Study Completion Date: April 6, 2023 https://clinicaltrials.gov/ct2/show/NCT04368728
Moderna Phase 2a Estimated Study Completion Date: November 1, 2021 https://clinicaltrials.gov/ct2/show/NCT04405076
Moderna Phase 3 Estimated Study Completion Date: October 27, 2022 https://clinicaltrials.gov/ct2/show/NCT04470427
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Yours sincerely
MHRA Customer Experience Centre
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