Accelerated Assessment of Comirnaty in Young People Commences

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

In a May 3, 2021 press release, the agency revealed that its Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data submitted by the company that markets Comirnaty. The data includes results from a large ongoing clinical study that involves adolescents from 12 years of age.

Any decision made by CHMP will be submitted to the European Commission, which will issue a final legally binding decision for the European Union. EMA will provide further information on the evaluation as it becomes available, which is expected to be in June should no additional information be required.