Europe Evaluates Comirnaty COVID-19 Vaccine for Adolescents

The European Medicines Agency (EMA) confirmed on May 3, 2021, it is evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include adolescents aged 12 to 15.

Known as the Pfizer-BioNTech vaccine in the USA, the Comirnaty is currently authorized for people aged 16 and older.

The EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by New York-based Pfizer and Germany-based BioNTech, including results from a large ongoing clinical study involving adolescents from 12 years of age, to decide whether to recommend the extension of indication.

The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. The EMA will communicate its evaluation outcome, which is expected in June 2021, unless supplementary information is needed.

The Comirnaty vaccine contains a molecule called messenger RNA with instructions for producing a protein, known as the spike protein, naturally present in SARS-CoV-2, the beta coronavirus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.

Comirnaty was first authorized in the EU in December 2020. The U.S. FDA Authorized the experimental Pfizer-BioNTech COVID-19 vaccine in 2020 but has not Approved it as of May 2021.