FOI release

Freedom of Information request on 1. The full list of ingredients in the Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) (PLGB 53632/0006) - (FOI 22/571)

Published 1 June 2022

FOI 22/571

25th March 2022

Dear

Thank you for your email.

Please find below answers to the questions you have raised.

  1. The full list of ingredients in the Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) (PLGB 53632/0006) is available in the SmPC from the MHRA website. A link to this is provided below:

https://mhraproducts4853.blob.core.windows.net/docs/3fa3caca6abf5080e37500abc7b9790223ad8e76

  1. Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) (PLGB 53632/0006) is authorised for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in children aged 5 to 11 years. This product is authorised via a reliance procedure following a European Commission (EC) decision. Further information, including the Public Assessment Report (PAR), is available from the European Medicines Agency (EMA). A link to this information is provided below:

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

Yours sincerely

MHRA Customer Experience Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000