The U.S. Food and Drug Administration (FDA) has accepted Pfizer and BioNTech's Biologics License Application (BLA) for full approval of their landmark mRNA COVID-19 vaccine for Americans 16 years of age and older, and will make a decision by January 2022, the companies announced in a statement Friday.
If approved, the Pfizer-BioNTech shot will be the first to receive such a designation in the U.S., which could go a long way toward combating vaccine hesitancy.
The FDA granted the two-shot vaccine, which was the first to receive Emergency Use Authorization (EUA) in Dec. 2020, Priority Review designation, meaning the FDA will aim to take action within 6 months rather than the typical 10 months of standard review. The companies completed the submission in May.
"This is another step forward in our ongoing efforts to provide protection against this awful virus," Pfizer's CEO Albert Bourla said, adding that the companies will submit a "supplemental BLA" to extend approval to 12- to 15-year olds as well.
Andy Slavitt, a former White House COVID-19 adviser, told CNN in June that approval could come quickly, but said that the process is complex.
"There's a lot of moving pieces," Slavitt said. "It's not as easy. Hopefully in the next four to five weeks, and I think that will be very, very good news."