The FDA approved the Pfizer/BioNTech SARS-CoV-2 vaccine (Comirnaty) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age.

Comirnaty has been approved for use in individuals 16 years of age and older since August 2021. The Pfizer-BioNTech COVID-19 Vaccine has been, and will continue to be, authorized for emergency use in this age group since May 2021.

The approval follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by FDA.