Pfizer and BioNTech on Friday started to apply for full approval of their COVID-19 vaccine from the Food and Drug Administration.
The companies will submit data to U.S. regulators on a rolling basis with an eye toward approval for ages 16 and up by later this year.
More than 170 million doses of the vaccine have been delivered across America under an “emergency use authorization,” meaning the benefits of the shots outweigh any perceived risks amid the raging pandemic.
Now, Pfizer and its German partner are seeking a Biologics License Application (BLA) that requires follow-up data as part of a rigorous review.
Securing full approval would, for instance, allow the product to stay on the market after the height of the COVID-19 crisis subsides.
Pfizer is the first drugmaker to seek full approval of a COVID-19 vaccine from the FDA. It was also the first to get emergency approval, in December, and is a leading option in the U.S. and other nations looking to defeat the virus.
The shots, like the ones from Moderna, use messenger-RNA technology. It delivers a snippet of genetic code, encased in bubbles of fat, that instructs the body to make imposters of the virus’ spike protein, so the system knows how to fight the real thing.