US finally approves Pfizer/BioNTech Covid-19 vaccine for emergency use By Agency
The US government has finally approved the Pfizer/BioNTech Covid-19 vaccine for emergency use.
The Food and Drug Administration is “rapidly” working toward clearing Pfizer’s Covid-19 vaccine for emergency use after a key panel overwhelmingly endorsed the shots Thursday evening, December 10, Commissioner Stephen Hahn said in a statement Friday.
Stephen Hahn, the Commissioner of Food and Drugs said in a statement on Friday December 11, that the Food and Drug Administration is “rapidly” working toward clearing Pfizer’s Covid-19 vaccine for emergency use after a key panel overwhelmingly endorsed the shots on Thursday evening.
“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” Hahn and Marks said.
Hahn added in a tweet that the FDA “is finalizing the necessary documents to ensure that patients and providers have the information that they need to make informed decisions and to safely administer the vaccine.”
The FDA’s comments come after the FDA’s Vaccines and Related Biological Products Advisory Committee on Thursday voted 17 to 4 with one abstention to recommend the vaccine, which the company developed alongside BioNTech, for emergency authorization.
The authorization of the vaccine should come “in the next couple of days,” Alex Azar, secretary of the Department of Health and Human Services, said on Friday on ABC’s “Good Morning America.”
“We’re looking at 20 million Americans being vaccinated just in the next coming weeks, up to 50 million total by the end of January, and we believe we can have 100 million actual vaccinations in arm by the end of February,” Azar said.
President Donald Trump, who has grown impatient with the authorization process in recent weeks, wrote in a tweet:
‘While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA Stop playing games and start saving lives!!!.’