Pfizer and BioNTech on Friday submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate, CNN reports.
This is the first coronavirus vaccine to seek regulatory clearance in the United States.
"It is with great pride and joy and even a little relief that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the FDA's hands," Pfizer CEO Albert Bourla said in a video shared on Friday. "This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day.
The vaccine, known as BNT162b2, could potentially be available for use in high-risk populations in the United States by the middle to end of December, Pfizer and BioNTech said in a statement earlier Friday. The vaccine requires two doses a few weeks apart, and protection is achieved 28 days after the first shot.
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 BioNTech said 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, CNN says.
