FOI release

Freedom of Information request on the regulatory approval of the COVID-19 vaccinations (FOI 22/413)

Published 31 May 2022

FOI 22/413

14th 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://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fcomirnaty&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=usadcf5VP50UPHoz%2BeiJzkp4x46SMZQ5ikiqBGlET14%3D&reserved=0

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://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fregulatory-approval-of-covid-19-vaccine-moderna&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=RlqrQOA4BV2uDb6QwdEIBSIvSvWbCI1JtpU20J%2FbZp8%3D&reserved=0

https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fcovid-19-vaccine-moderna&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=fujai3SxxqCjfNVS6uLGFMDYFtg9KgK3%2FloHD7jGJwQ%3D&reserved=0

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://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fregulatory-approval-of-covid-19-vaccine-janssen&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=903E%2F33GnmT9aBm%2FJRgZnisHyJ%2B72Fq%2BvG%2BQ2YCmXoY%3D&reserved=0

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://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fregulatory-approval-of-covid-19-vaccine-astrazeneca&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=vjuWAJS1hwkM4tVK3XJhbDpkohI6DefdXsm7xan3Xvo%3D&reserved=0

https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fvaxzevria-previously-covid-19-vaccine-astrazeneca&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=et2liLk0zGFqnbvtsHjKHXEItbLCeHtHQsJPmlK4%2F2E%3D&reserved=0

A conditional marketing authorisation was granted for Novavax vaccine on 3 February 2022. Further information is available via the below links.

https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fnews%2Fnovavax-covid-19-vaccine-nuvaxovid-approved-by-mhra&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=5t6xZh0iXobIF3CnSpsJ68vG5L%2B7hNWVKrod9z6YDNQ%3D&reserved=0

https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fregulatory-approval-of-covid-19-vaccine-nuvaxovid&data=04%7C01%7CMHRACustomerServices%40mhra.gov.uk%7C253d42be6c934f32ec8508d9ea4b6035%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637798431720912455%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=q7E%2BPZl4xlZ0JpzpGB4sio2q5TIQspfgim9SnDhORlM%3D&reserved=0

Please note that the full list of excipients is provided in Section 2 and Section 6.1 of the SmPC for the authorised vaccines, links above have been provided.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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