Pfizer's COVID-19 vaccine is facing one more hurdle as it races to become the first shot greenlighted in the United States: a panel of experts who will scrutinize the company's data for any red flags.
The FDA advisory panel functions like a science court. During a daylong session Thursday, it is expected to debate and pick apart the data on whether the vaccine is safe and effective enough to be cleared for emergency use. It will then vote on whether to recommend granting emergency use authorization.
The FDA is not required to follow the committee's advice but is widely expected to do so. Once it is authorized by the FDA, the U.S. will begin shipping millions of doses of the shot, which has been shown to offer strong protection against the coronavirus.
How to watch the FDA committee's vote on the Pfizer COVID-19 vaccine
- What: The FDA's Vaccines and Related Biological Products Advisory Committee meets to discuss and vote on the request for emergency use authorization for a COVID-19 vaccine from Pfizer, in partnership with BioNTech Manufacturing.
- Date: Thursday, December 10, 2020
- Time: Approximately 3:10 - 5 p.m. ET
- Online stream: Live in the player above and on your mobile or streaming device
The FDA's decision will come as the coronavirus continues surging across the nation and much of the world, claiming more than 1.5 million lives globally, including more than 289,000 in the U.S., according to the tally kept by Johns Hopkins University. The U.S. death toll far surpasses the number anywhere else, exceeding the nation with the second-most, Brazil, by some 110,000.
The U.S. just set a single day record on Wednesday of more than 3,000 COVID-19 deaths, as noted by Vice President-elect Kamala Harris:
Columbia University biologist Dr. Lucky Tran called it "a historic tragedy." Last week the U.S. recorded four of the deadliest days in the nation's history.
U.S. hospitals are filling up. More than one-third of all Americans live near hospitals that are critically short of intensive care unit beds, according to The New York Times.
Plans for an ambitious nationwide vaccination program are ramping up to begin distributing shots as soon as the FDA gives the OK. Health care workers would be among the first in line.
But hanging over the FDA meeting is a warning from U.K. 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 earlier this week.
Still, a positive recommendation and speedy U.S. approval seem nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.
The agency said results from Pfizer's large, ongoing study showed the shot, which was co-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 issues 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' International Vaccine Access Center. "Nothing that I see would delay an emergency use authorization."
The meeting also gives regulators an opportunity 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 verbal abuse 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 has 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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