Pfizer, BioNTech seek full FDA approval of COVID-19 vaccine
Pfizer and BioNTech on Friday said that they have begun their request for the Food and Drug Administration (FDA) to give full approval of their COVID-19 vaccine after having emergency use authorization for almost five months.
The companies announced they started their Biologics License Application (BLA) for the FDA to grant full authorization to give their vaccine to those 16 and older.
With the FDA’s full approval, the Pfizer-BioNTech vaccine could be given to patients after the public health emergency is declared over.
The Pfizer-BioNTech vaccine would be the first in the U.S. with the FDA’s full approval.
In a press release, Pfizer and BioNTech said they plan to submit data for their BLA “on a rolling basis over the coming weeks” and ask for priority review for a decision to be made within six months instead of the standard 10 months.
The companies have to send in information on their manufacturing processes, their facilities and pre-clinical and clinical trial data for the application.
A planned decision date will be set after the application is complete and the FDA officially accepts it.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Pfizer Chairman and CEO Albert Bourla said.
“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,” he added.
The companies’ two-shot mRNA vaccine on Dec. 11 became the first to receive the FDA’s emergency use authorization, followed by the Moderna and Johnson & Johnson vaccines.
Since then, the companies said more than 170 million doses have been distributed across the country.
Centers for Disease Control and Prevention data shows that more than 134 million doses have been administered, more than half of all doses given out in the country.
Pfizer and BioNTech have also requested emergency use authorization to give their vaccine to 12- to 15-year-olds, which is expected to be granted in the coming days.
The companies said they plan to submit a supplemental application to get full approval for that age group once they have six months of data following the second dose.
The request for full approval also comes after researchers at Pfizer and the Israeli Ministry of Health found the vaccine was about 95 percent effective at preventing infection, hospitalization and death from variants.
The Pfizer-BioNTech vaccine was also determined to be more than 91 percent effective in preventing symptomatic COVID-19 at least six months after the second dose.
Updated at 7:42 a.m.