Pfizer and BioNTech announced early Friday that they have begun the process to request full approval for their COVID-19 vaccine from the U.S. Food and Drug Administration.
In a news release, the companies said they have started a Biologics License Application with the FDA for full approval of the mRNA vaccine for use in people ages 16 and older.
“Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for priority review,” the release said.
Of more than 170 million doses delivered, about 134 million doses of Pfizer-BioNTech’s two-shot vaccine, which the FDA approved in December for emergency use in people ages 16 and up, have been administered in the U.S., according to the latest data from the Centers for Disease Control and Prevention. The vaccine was the first of three to receive emergency use authorization in the country.
A BLA requires longer-term follow-up data than an EUA, the companies said.
“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’s chairman and CEO, Albert Bourla, said in a statement. “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.”
The most recent results from the companies’ Phase 3 trial found that the vaccine remains 90% effective against symptomatic disease six months after adult participants received both doses, according to an April news release.
On March 31, the company said its vaccine has been 100% effective in a clinical trial of children ages 12 to 15, according to preliminary results. The New York Times, The Washington Post and The Associated Press, all citing unnamed government officials, reported Monday that the vaccine is expected to be approved next week for emergency use in that age group.
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Cox Media Group
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