Pfizer and BioNTech have expressed readiness to submit to the US Food and Drug Administration today for an emergency use authorization for their coronavirus vaccine candidate.
This is the first coronavirus vaccine to seek a regulatory OK in the United States, CNN reports.
The companies said in a statement 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.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer CEO Albert Bourla said in a statement.
Moderna, another pharmaceutical company, announced Monday that early clinical trial results show its vaccine is 94.5% effective. The company plans to apply to the FDA for authorization after it accumulates more safety data later this month.
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 is available for approval. For an EUA, the agency says it will determine whether a product’s “known and potential benefits outweigh its known and potential risks.”