The COMIRNATY® vaccine (BioNTech and Pfizer laboratories) obtained conditional marketing authorization (AMM), in Europe (centralized procedure), on 12/21/2020 (2, 3) “for active immunization for prevention of COVID-19 caused by the SARS-CoV-2 virus, in people aged 16 and over ”, with an extension of its indication to adolescents from 12 to 15 years old on 05/28/2021.

These recommendations are part of an extension of the Marketing Authorization for the COMIRNATY® mRNA vaccine developed by the companies BioNTech and Pfizer and therefore aim to clarify its place in view of the vaccine efficacy and safety data in adolescents from 12 to 15 years old.

The summary can be found in the attachment above and the full text can be accessed here

Recommendation Europe France adolescents Pfizer-BioNTech vaccine COVID-19