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FDA has authorized the first COVID-19 vaccine [Updated]

The US Food and Drug Administration
Pfizer and BioNTech
Center for Biologics Evaluation and Research
the Pfizer-BioNTech COVID-19
the Trump Administration
the Emergency Use Authorization
Pfizer/BioNTech COVID-19
the Washington Post
White House
the New York Times
the Ars Orbital Transmission
CNMN Collection WIRED Media Group
Condé Nast

Beth Mole
Peter Marks
Stephen Hahn
Mark Meadows
Hahn @SteveFDA


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the United States

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Positivity     31.00%   
   Negativity   69.00%
The New York Times
Write a review: Ars Technica

Today's achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine."Immediately after the agency announced the authorization, President Trump released a video message touting the achievement.Distribution of the vaccine is expected to begin in the coming days.Original story 4:27pm EST:The US Food and Drug Administration may finalize authorization for the first COVID-19 vaccine later today, Friday, which would accelerate an already breakneck regulatory pace in the wake of intense pressure and threats from the Trump Administration.According to multiple reports, the FDA was expecting to finalize the Emergency Use Authorization for the two-dose Pfizer/BioNTech COVID-19 vaccine early Saturday. That final sign off would land less than 48 hours after the agency's independent advisory committee endorsed granting the EUA in a vote late Thursday of 17 to 4, with one abstention.Earlier this week, the FDA released a briefing of its own review of the Pfizer/BioNTech mRNA vaccine, finding it "highly effective" and with a "favorable safety profile."In a joint, early-morning statement today, FDA commissioner Stephen Hahn and Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said the finalized EUA was imminent.

As said here by Beth Mole