Pfizer and BioNTech announced the FDA approval of the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.
The vaccine has been available in the United States under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 vaccine). The EUA permitted essential rollout of vaccine doses across the United States to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial.
For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. The BLA submission package also included the manufacturing and facilities data required for licensure. Pfizer and BioNTech completed submission of the BLA in May 2021, and the BLA was granted Priority Review in July 2021.
As announced on August 16, Pfizer and BioNTech plan to seek licensure of a booster, dose of COMIRNATY in individuals 16 years of age and older via a supplemental BLA. The companies also intend to submit a supplemental BLA to support potential full FDA approval of COMIRNATY in individuals 12 through 15 years of age once the required data out to six months after the second vaccine dose are available. In the meantime, the vaccine remains available to 12- to 15-year-olds under the Emergency Use Authorization (EUA) granted by the FDA on May 10, 2021. For individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, a third dose of the vaccine also remains available under EUA following an amendment by the FDA on August 12.
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