FDA Approves Emergency Use of Pfizer-BioNTech COVID-19 Vaccine

The Pfizer/BioNTech Covid-19 vaccine has finally been approved for emergency use by 
the US government. 
Pfizer seeks US FDA approval for COVID-19 vaccine's emergency use | Business and Economy News | Al Jazeera
After main panel overwhelmingly endorsed the shots on Thursday evening, December 10, 
Commissioner Stephen Hahn said in statement Friday, the Food and Drug Administration is ”rapidly” working towards clearing Pfizer’s Covid-19 vaccine for emergency use.
Stephen Hahn, the Commissioner of Food and Drugs said in 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 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 joint statement with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Hahn and Marks said. “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,”
In tweet, Hahn added that the FDA ”is finalizing the documents necessary to ensure that 
patients and providers have the information they need to make informed decisions and safely administer the vaccine.”
The FDA’s comments come after the FDA’s Advisory Committee on Vaccines and Related Biological Products on Thursday voted 17 to with one abstention for emergency permission to approve the vaccine produced by the company alongside BioNTech. 
Alex Azar, Secretary of the Department of Health and Human Services, said on Friday on 
ABC’s “Good Morning America,” the authorization for the vaccine could arrive “in the next few days.”
“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 the arm by the end of February,” Azar said.
President Donald Trump, who in recent weeks has become dissatisfied with the authorization process, wrote in 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!!!.’

‘FDA APPROVES PFIZER VACCINE FOR EMERGENCY USE!!!, Trump added in another tweet as soon as the approval was announced.

 

 

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