BOSTON (CBS/AP) – Pfizer is asking the Food and Drug Administration to allow emergency use of its COVID-19 vaccine, starting a process that could bring first shots as early as next month.
Pfizer said on Friday afternoon that they, along with their German partner BioNTech, have submitted an Emergency Use Authorization (EUA) request to the FDA.
“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,” said Albert Bourla, Chairman and CEO of Pfizer Inc., in a Twitter video on Friday. “This is a historic day, a historic day for science, and for all of us.”
— Pfizer Inc. (@pfizer) November 20, 2020
Friday’s step comes days after Pfizer and BioNTech announced its vaccine appears 95% protective in a large but not yet finished study.
Pfizer said of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. More than 100 of the volunteers participated through UMass Memorial Medical Center in Worcester.
Over the next few weeks, the Food and Drug Administration and its scientific advisers will have to decide if there’s really enough evidence to allow emergency vaccinations.
If so, first supplies will be scarce and rationed. Experts warn it likely will be spring before there’s enough for everyone.
Pfizer has three vaccine manufacturing sites in the U.S. including one in Andover.
(© Copyright 2020 CBS Broadcasting Inc. All Rights Reserved. Associated Press Medical Writer Lauran Neergaard contributed to this report.)