Pfizer and BioNtech begin the process of seeking full FDA approval for their Covid vaccine
Pfizer and German drugmaker BioNTech said they've started the process of seeking full approval for ther Covid-19 vaccine for use in people 16 and older in the U.S., making the companies the first in the nation to file for full regulatory approval.
The Food and Drug Administration granted emergency authorization of their Covid vaccine in late December. Since then, Pfizer has distributed 170 million doses in the U.S., with the goal of delivering 300 million doses by the end of July.
"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 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."
Pfizer will have to demonstrate that it can reliably produce the vaccines to win full clearance. If approved, the companies could market their shots directly to consumers and possibly change the pricing of the doses. 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."
It usually takes the FDA about a year or longer to determine whether a drug is safe and effective for use in the general public. Due to the once-in-a-century pandemic, which has killed nearly 600,000 people in the United States, the FDA permitted the use of the shots under an Emergency Use Authorization.
The authorization grants conditional approval based on two months of data. It's not the same as a Biologic License Application, which requires six months of data and secures full approval. The companies are seeking approval based on a "rolling submission," which expedites the review process by allowing the FDA to review new data as the company gets it.
"The BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future," Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement. "We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data."
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