Why is the Pfizer COVID-19 vaccine not yet approved for individuals age 12-15?

Pfizer’s application for FDA approval was for use in individuals age 16 and older. The FDA issued the EUA for the Pfizer COVID-19 vaccine in December 2020, at which time this vaccine was authorized for use in individuals age 16 and older. In May 2021, based on extensive effectiveness and safety data in clinical trials of adolescents, the EUA was expanded to include those 12 through 15 years old. Pfizer plans to request full approval for this age group once it has collected and analyzed six months of safety data from clinical trial participants. The EUA remains in place for individuals age 12 through 15, and the CDC continues to recommend that all adolescents and adults age 12 and older get a COVID-19 vaccine.

Added August 23, 2021