Pfizer and its partner BioNTech have asked the Food and Drug Administration for full approval of their coronavirus vaccine for people ages 16 and over.
The vaccine and two others are currently available in the United States under an emergency authorization from FDA. Pfizer and BioNTech are the first Covid-19 vaccine makers to seek full approval from U.S. regulators, which would allow the companies to market the shot directly to consumers. It could also make it easier for schools, employers and the military to require vaccination against Covid-19.
Pfizer and BioNTech also asked the regulatory agency to allow an expansion of emergency use of the vaccine to people ages 12 to 15.
The U.S. has purchased 400 million doses of Pfizer’s vaccine, enough for 200 million people — making it a pillar of the country’s vaccination push. The shot is currently available for people ages 16 and older, and Pfizer and BioNTech are now studying the vaccine in children as young as 6 months. The companies have said they expect more results from the child study by September.
FDA authorized the vaccine in December 2020 after reviewing data from a clinical trial that enrolled more than 37,000 people 16 and older in the U.S., Europe, South Africa and South America. Now that Pfizer and BioNTech have applied for full approval in adults, the agency will more closely evaluate the shot’s overall safety and efficacy, a higher bar than emergency use authorization — which FDA grants when there is evidence that a vaccine may confer a benefit.
Pfizer has shared data with FDA about its vaccine’s long-term efficacy, as well as potential changes in handling requirements, such as evidence that the vaccine can be refrigerated for longer periods, rather than requiring ultra-cold storage temperatures.
While FDA approval reviews typically take six months or more, the agency could act quickly on the vaccine since it had already received authorization. There is precedent: FDA approved Gilead’s coronavirus treatment Veklury — also known as remdesivir — roughly two months after Gilead filed.
“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Pfizer CEO Albert Bourla said in a statement.
David Lim contributed to this report.