Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved 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 U.S. 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 U.S. 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.

“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60 percent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval.”

“Today's full approval by the FDA underlines the vaccine's high efficacy and favorable safety profile,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”

As announced on August 16, Pfizer and BioNTech plan to seek licensure of a third, or 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.

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 and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

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