The Covid-19 vaccine made by Pfizer Inc. and BioNTech SE was granted a full approval by U.S. regulators, a move that is expected to help bolster the immunization drive amid a surge in infections caused by the delta variant.
The Food and Drug Administration said in a statement on Monday that it had cleared the vaccine for the prevention of Covid-19 in individuals 16 years of age and older. It will be marketed under the Comirnaty.
The vaccine continues to be available to people age 12 to 15 under an emergency-use authorization, the agency said.
Pfizer shares rose 2.4% at 9:45 a.m. in New York trading on Monday.
The approval is expected to boost confidence in the shot and is likely to open the door to more vaccine mandates among employers and businesses. It is also likely to solidify its future as a blockbuster for its makers.
Pfizer and BioNTech approached the FDA in May with a so-called Biologics License Application or BLA, prompting even greater scrutiny of the two-shot regimen.
“The FDA’s review of a BLA is among the most comprehensive in the world,” the agency said in an email earlier this month. “We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval.”
The companies’ submission was delivered in two batches. On May 7, they shared a package of clinical data including more information on the vaccine’s effectiveness and six months of safety data — building on two months of safety data shared in the emergency-use application.
Two weeks later, Pfizer and BioNTech shared information on the vaccine’s manufacturing processes and production facilities.
Altogether, the application was 340,000 pages, more than three times the length of the emergency-authorization submission. According to Pfizer, that’s significantly longer than the standard application package.
Though the BLA review process typically takes eight months, U.S. regulators said they turned to “sprint teams” to evaluate “a tremendous amount of data.” The review was ultimately concluded in less than half the time.
Pfizer expects to file a BLA for its vaccine in those age 12-to-15 before the end of the year. For those under 12, the process will take even longer. Neither Moderna Inc. nor Johnson & Johnson have yet approached U.S. regulators with a Biologics License Application for any age group.