FDA Extends Full Approval of Pfizer's COVID-19 Vaccine to 12- through 15-Year-Olds

On July 9, the FDA issued full approval of Pfizer's COVID-19 vaccine (marketed as COMIRNATY) for immunization in adolescents 12 through 15 years of age.

The approval followed FDA's rigorous analysis and evaluation of the vaccine's safety and effectiveness data in this age group. Pfizer's COVID-19 vaccine has been approved for use in individuals 16 years of age and older since August 2021.