Start of the Evaluation Process for the Approval Extension of the COVID-19 Vaccine Comirnaty for Children from 5 Years of Age

The European Medicines Agency (EMA) announced on 18 October 2021 that the Committee for Medicinal Products for Human Use (CHMP) has started evaluating the application to extend the use of BioNTech/Pfizer's COVID-19 vaccine, Comirnaty, to children aged five to eleven years.

The CHMP at EMA will review especially the results of an ongoing clinical trial with children aged five to eleven years, in order to decide whether to recommend extending the vaccine's use to the aforementioned age group. The CHMP's opinion will then be forwarded to the European Commission, which will issue a final decision. This decision will then be valid in all EU member states.

The outcome of the CHMP assessment is expected in a few months, unless supplementary information is required.

The COVID-19 vaccine Comirnaty received a conditional marketing authorisation in the European Union (EU) on 21 December 2020, from the age of 16. The marketing authorisation extension for children and adolescents from 12 to 15 years of age was granted on 31 May 2021.