Pfizer and the German company BioNTech have become the first companies to apply to the U.S. Food and Drug Administration for full approval of their Covid-19 vaccine for use in people 16 and older. The vaccine is currently being administered to adults in America under an emergency use authorization granted in December.
The approval process is likely to take months.
The companies said in a statement on Friday that they had submitted their clinical data, which includes six months of information on the vaccine’s safety and efficacy, to the F.D.A. They plan to submit additional material, including information about the manufacturing of the vaccine, in the coming weeks.
“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,” Dr. Albert Bourla, Pfizer’s chief executive, said in the statement. “We look forward to working with the F.D.A. to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention. Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.
said in December that employers could mandate vaccination, and legal experts have generally agreed.
Many companies have been hesitant to require the vaccines, especially while they have only
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