Shares of Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) climbed on Friday after the pharmaceutical giant and biotech said they would request Emergency Use Authorization (EUA) for their experimental coronavirus vaccine.
As of 11:15 a.m. EST, Pfizer's and BioNTech's stocks were up 1.2% and 6.7%, respectively.
Pfizer and BioNTech will submit an EUA request to the U.S. Food and Drug Administration (FDA) today. The companies said they've already made similar requests to health regulators in international markets, such as Canada, the U.K., and Japan.
Pfizer and BioNTech's vaccine candidate, BNT162b2, could be as much as 95% effective at preventing COVID-19, as demonstrated by their phase 3 clinical trial results. Better still, no serious safety concerns have been observed in the study's participants to date.
"Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," Pfizer CEO Albert Bourla said in a press release. "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."
If the FDA grants an EUA in the coming weeks, Pfizer and BioNTech could potentially make their vaccine available to Americans who are deemed to be at high-risk of contracting COVID-19 by the end of December. The healthcare companies have been ramping up their manufacturing and distribution capabilities so as to be able to produce up to 50 million doses worldwide in 2020 -- and up to 1.3 billion doses by the end of 2021. They stand ready to distribute their vaccine candidate "within hours after authorization."
"Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible," BioNTech CEO Ugur Sahin said. "We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally."