Pfizer and BioNTech asked the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine on Friday (May 7). If the FDA signs off on the vaccine, it will be the first one in the United States to be considered FDA-approved.
All the vaccines currently being distributed in the U.S. were granted an emergency use authorization, which requires just two months of safety and efficacy data. Companies must apply for a biologics license application to be granted full approval and provide at least six months of data to the FDA. They must also submit information about the manufacturing process, the production facilities, proof that the vaccine can be produced consistently, and all of the data from the pre-clinical and clinical trials.
"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 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 submit the data to the FDA over the next few weeks on a rolling basis. The drugmaker has asked the FDA for a priority review, which takes about six months.
The approval would only be for people 16 and older. Pfizer has already filed a request for an emergency use authorization for the vaccine in children between the ages of 12 and 15. That decision is expected to be made in the coming week.
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