Enlarge /. Stephen Hahn, Commissioner for the US Food and Drug Administration.
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The U.S. Food and Drug Administration could finalize approval for the first COVID-19 vaccine today, Friday, which would accelerate an already rapid regulatory pace due to heavy pressure and threats from the Trump administration.
According to several reports, the FDA was expecting to complete emergency approval for the Pfizer / BioNTech double-dose COVID-19 vaccine early Saturday. This final approval would come less than 48 hours after the Agency's independent advisory committee agreed to the grant of EEA in a 17-4 with one abstention vote late Thursday.
Earlier this week, the FDA released a briefing about its own review of the Pfizer / BioNTech mRNA vaccine and found it to be "highly effective" and with a "favorable safety profile".
In a joint statement earlier this morning, FDA Commissioner Stephen Hahn and Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said the final EEA was imminent. "Following yesterday's positive outcome from the advisory committee meeting …" the FDA will be working swiftly towards finalization and emergency approval. "
But the agency's quick work didn't seem quick enough for the Trump administration.
White House Chief of Staff Mark Meadows told Hahn this afternoon to resign if the agency doesn't finalize approval by the end of the day, according to a Washington Post report. The Post cited unnamed sources familiar with the situation but not empowered to discuss it with the press. Hahn has since denied that he was threatened.
Meanwhile, Trump was raging at the FDA on Twitter, writing, "While my pressure on the soaked but heavily bureaucratic @US_FDA saved five years in getting NUMEROUS great new vaccines approved, it's still a big, old, slow turtle. Get Get Down The Dam Vaccines NOW, Dr. Hahn @SteveFDA. Stop Gambling and Save Lives !!! "
FDA regulators are now rushing to fill out a vaccine fact sheet, physician information and other documents required to complete the approval, the New York Times reports. Pfizer is also likely to come under pressure as certain documents need to be reviewed before approval is finalized.
It's important that the difference between late Friday and early Saturday approvals doesn't affect when a vaccine actually ships and reaches Americans, according to the Times.
In an interview with ABC's Good Morning America, Secretary of Health and Human Services Alex Azar said, "We saw people being vaccinated on Monday, Tuesday of next week."
While the political drama may worry some that the regulatory review of the vaccine has been accelerated, it should be noted that the FDA's independent advisory panel was overwhelmingly enthusiastic about the approval of the EUA emission. Only four of the committee's 22 voting members voted against the approval of the approval and one abstained.
At least some of these voices were due to the age set for access to vaccines, rather than major concerns about safety or effectiveness. The EEA was issued to people aged 16 and over, while some members of the Advisory Board felt that it should be limited to ages 18 and over for the time being, pending further data on pediatric studies. If the age limit had been raised slightly, the committee could have voted almost unanimously – if not unanimously – for the EEA.