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WASHINGTON — A U.S. government advisory panel convened Dec. 10 to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.
The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in U.S. history. Depending on how fast the FDA signs off on the panel’s recommendation, shots could begin within days.
The FDA panel functions like a science court. During the scheduled daylong session, it was expected to debate and pick apart the data — in public and live-streamed — on whether the vaccine is safe and effective enough to be cleared for emergency use.
“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said FDA’s Dr. Doran Fink, who described agency scientists working nights, weekends and over Thanksgiving to get that done.
With unprecedented interest in the normally obscure panel, the FDA broadcast the meeting via YouTube, and thousands logged on to follow the discussion.
The FDA is not required to follow the committee’s advice but is widely expected to do so. Once that happens, the U.S. will begin shipping millions of doses of the shot.
The meeting came as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including more than 289,000 in the U.S.
Hanging over the meeting is a warning from British officials that people with a history of serious allergic reactions shouldn’t get the vaccine. Government officials there are investigating two reports of reactions that occurred when the country began mass vaccinations on Dec. 8.
Still, a positive recommendation and speedy U.S. approval appeared nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.
FDA said results from Pfizer’s large, ongoing study showed that the shot, which was developed with Germany’s BioNTech, was more than 90% effective across people of different ages, races and underlying health conditions, including diabetes and obesity. No major safety problems were uncovered, and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable.
“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins University’s International Vaccine Access Center. “Nothing that I see would delay an emergency use authorization.”
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The meeting also represented an opportunity for regulators to try to boost public confidence in the breakneck development process that has produced the Pfizer-BioNTech vaccine and a string of other upcoming shots in less than a year.
The FDA has also faced weeks of criticism from President Donald Trump for not rushing out a vaccine before Election Day.
“There have been a lot of questions about why it takes us so long or ‘are we being rigorous enough?’ ” said FDA Commissioner Stephen Hahn in an interview. “I’m hoping that people will see with our transparency that we have taken a very rigorous stance on this.”
Hahn said the agency had already teed up the process to authorize the vaccine by filling out all the legal paperwork in advance, regardless of the ultimate decision.
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