EMA Considers Adolescent Booster-Dose Application for Comirnaty

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

The European Medicines Agency (EMA) has started its evaluation of an application for the use of a booster dose of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, in adolescents aged 12–15 years.

As reported in a Feb. 8, 2022 press release, EMA’s Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data that has been submitted by the company responsible for marketing Comirnaty. The data that has been submitted includes real-world evidence from Israel.

Currently, the booster doses of Comirnaty are approved to be administered in patients aged 18 years and older. An application for a booster dose of the vaccines in patients aged 16–17 years is also ongoing.

EMA will provide further information and updates on the evaluation in due course.

Source: EMA