Pfizer and BioNTech have submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate.
“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 took just 248 days to get from the day we announced our plans 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 maintaining our focus on safety.”
This is the first coronavirus vaccine to seek a regulatory OK in the United States. Pfizer and BioNTech said 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 the middle to end of December.
The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers. The final analysis from the trial found the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer and its German partner, BioNTech, announced this week. The submission also includes safety data on about 100 children ages 12 to 15.
About 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds, the companies said in a news release, and 41% of global and 45% of US participants are ages 56 to 85.
Another possible vaccine candidate: Moderna, another pharmaceutical company, announced Monday that early results from its clinical trials show their vaccine is 94.5% effective. The company plans to apply to the FDA for authorization after it accumulates more safety data later this month.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for Dec. 8, 9 and 10, a source familiar with the process told CNN this week. The agency could make a decision at the end of the meeting on Dec. 10 about whether to issue an emergency use authorization, the source said.
Emergency use authorization, or EUA, from the FDA is not the same as full approval. An EUA allows products to be used under particular circumstances before all the evidence needed for approval is available. The agency must determine the product’s “known and potential benefits outweigh its known and potential risks.”