EMA Issues Positive Opinion on Pfizer and BioNTech COVID-19 Vaccine Booster in Adolescents 12 Through 17 Years of Age in EU

Pfizer and BioNTech announced on Feb. 24, 2022 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the companies’ COVID-19 booster for use in adolescents 12 through 17 years of age. The CHMP recommendation will be reviewed by the European Commission (EC), and a final decision on a variation to the Conditional Marketing Authorization is expected in the near future. If the variation is granted, the decision will immediately apply to all 27 EU member states, which will make booster vaccines available to all individuals 12 years and older.

FDA already granted Emergency Use Authorization (EUA) for the vaccine booster for individuals 12 to 15 years of age in the United States earlier this year. Currently, the Pfizer-BioNTech vaccine is the only COVID-19 vaccine authorized for this age group in the US and Europe.

CHMP based their positive opinion on an evaluation of safety and efficacy data from a clinical trial of a booster dose of the vaccine in those 16 and older, as well as published literature, post authorization data, and real-world evidence from booster doses in young patients in Israel. CHMP deemed the evidence concluded that the booster dose in adolescents would be at least equal to that in adults with no new safety concerns identified.

Pfizer and BioNTech will continue to supply the vaccine under their existing supply agreement with the EC.

Source: Pfizer