8 July 2022 - Approval of the two dose primary series is based on the totality of data through six months post dose 2 in individuals 12 through 15 years of age.
Pfizer and BioNTech today announced the U.S. FDA approved the companies’ supplemental biologics license application for their COVID-19 vaccine, known as Comirnaty (COVID-19 vaccine, mRNA), to include individuals 12 through 15 years of age.
The vaccine was previously made available to this age group in the U.S. under emergency use authorisation and to date more than 9 million 12 to 15 year-old adolescents in the U.S. have completed a primary series.