July 11, 2022 – Pfizer and BioNTech announced the FDA approved the companies’ supplemental Biologics License Application (sBLA) 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 authorization (EUA), and to date more than 9 million 12- to 15-year-old adolescents in the U.S. have completed a primary series.
COMIRNATY is now the only COVID-19 vaccine approved by the FDA as a two-dose primary series for individuals 12 years and older. An EUA for a primary series in U.S. adolescents ages 12 through 15 years was previously granted in May 2021 based on initial data from the same pivotal Phase 3 clinical trial. Longer-term follow-up data, announced in November 2021, confirmed the safety and effectiveness of COMIRNATY in adolescents 12-15 years of age and were required for licensure. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021.
COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Pfizer and BioNTech have also submitted a sBLA to the U.S. FDA to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA.
COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Pfizer and BioNTech also are pursuing regulatory approvals for this age group in other countries where emergency use authorizations or equivalents have been granted.