Pfizer and BioNTech have begun the process of applying for full approval from the U.S. Food and Drug Administration of its coronavirus vaccine, the companies announced Friday morning.
The vaccine was approved for emergency use on Dec. 11, 2020, and the companies say they have since delivered 170 million doses across the United States.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in the 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 emergency use authorization grants conditional approval based on two months of data. It's not the same as full FDA approval, also known as a Biologic License Application, which requires six months of data and secures full approval, CNBC reports.
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If the vaccine is fully approved, it sets the stage for Pfizer and BioNTech to begin advertising the shots directly to consumers and change its pricing. It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an "emergency."
