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Pfizer and BioNTech have submitted emergency use authorization for their coronavirus vaccine candidate to the United States Food and Drug Administration.
“This is a historic day, a historic day for science and for all of us,” Pfizer CEO Albert Bourla said in a video shared on Friday. “It only took 248 days to go from the day we announced our intention to collaborate with BioNTech to our FDA submission day. We have operated at extraordinary speed in our clinical development program, from concept to regulatory filing, while always keeping the focus on safety.
It is the first coronavirus vaccine to seek regulatory agreement in the United States. Pfizer and BioNTech said in a statement Friday that their vaccine candidate, known as BNT162b2, will potentially be available for use in high-risk populations in the United States by mid-December.
The submission to the FDA is based on the results of Pfizer’s Phase 3 vaccine clinical trial, which began in the United States on July 27 and recruited more than 43,000 volunteers. Final analysis of the trial found that the coronavirus vaccine was 95% effective at preventing infections, even in the elderly, and posed no serious safety concerns, Pfizer and its German partner announced this week. , BioNTech. The submission also includes safety data on approximately 100 children aged 12 to 15.
About 42% of global participants and 30% of US participants in the Phase 3 study are of diverse racial and ethnic backgrounds, the companies said in a press release, and 41% of global participants and 45% of US participants have between 56 and 85 years old.
Another possible vaccine candidate: Moderna, another pharmaceutical company, announced Monday that the first results of its clinical trials show that its vaccine is 94.5% effective. The company plans to seek clearance from the FDA after it accumulates more safety data later this month.
The FDA has scheduled a meeting of its Vaccines and Related Biologics Advisory Committee, an external panel of experts, for December 8, 9 and 10, a source familiar with the process told CNN. The agency could make a decision at the end of the December 10 meeting on whether to issue an emergency use authorization, the source said.
The Emergency Use Authorization, or EUA, from the FDA is not the same as full approval. An EUA allows products to be used in specific circumstances before all the evidence necessary for approval is available. The agency must determine that “the known and potential benefits of the product outweigh its known and potential risks.”
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