US officials have endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak.
The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. The advisory group, in 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.
A final FDA decision is expected within days. Millions of shots would then ship to begin vaccinating health care workers and nursing home residents. Widespread access to the general public is not expected until the spring.
On Wednesday, the US recorded 3,046 Covid-19 deaths in a single day, a pandemic record. That’s more than the entire death toll of the 9/11 attacks in 2001 which claimed the lives of 2,996 people.
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 — on whether the vaccine is safe and effective enough to be cleared for emergency use. With unprecedented interest in the normally obscure panel, the FDA broadcast the meeting via Youtube, and thousands logged on.
“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.
The FDA is not required to follow the committee’s advice but is widely expected to do so. Once that happens, the US will begin shipping millions of doses of the shot.
Later this month, the FDA is expected to pass judgment on another vaccine, developed by Moderna and the National Institutes of Health, that has proved about as protective as Pfizer’s. Vaccine candidates by Johnson & Johnson and AstraZeneca are also in the pipeline.
The initial supplies from Pfizer and Moderna will be limited and reserved primarily for health care workers and nursing home patients, with other vulnerable groups next in line until the shots become widely available on demand, something that will probably not happen until the spring.
The meeting of experts on vaccine development, infectious diseases and medical statistics came as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including about 290,000 in the US.
Hanging over the meeting was a warning from British officials that people with a history of serious allergic reactions shouldn’t get the vaccine. Government authorities there are investigating two reports of reactions that occurred on Tuesday when Britain became the first country in the West to begin mass vaccinations against the scourge.
Pfizer representatives told the panel they are aware of the British reports but have seen no signs of allergic reactions in their trial of the vaccine.
– Associated Press
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