The Food and Drug Administration (F.D.A) on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to move beyond emergency-use status in the United States.
The decision is sure set off a cascade of vaccine requirements by hospitals, colleges, corporations, and others. The Pentagon responded immediately, with Lloyd J. Austin III, the defense secretary, poised to send guidelines to the country’s 1.4 million active-duty service members requiring that they be vaccinated, the Biden administration said on Monday.
Oregon has adopted a vaccine requirement for all state workers, as have universities in Louisiana and Minnesota. And in New York City, Mayor Bill de Blasio said on Monday that all education department employees would have to be vaccinated by Sept. 27, without the option of submitting to coronavirus testing instead.
The F.D.A. approval comes as the fight against the pandemic has intensified again in the United States, with the highly infectious Delta variant drastically slowing the progress the country had made in the first half of the year. There are now an average of around 150,000 new cases a day in the United States, and more than 90,000 hospitalized Covid-19 patients.
In a brief speech on Monday, President Biden said he hoped the approval would prompt many of the roughly 85 million Americans who are unvaccinated and eligible for shots to get them.
Dr. Janet Woodcock, the drug administration’s acting commissioner said in a statement that “we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated.”
A recent poll by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, found that 3 in 10 unvaccinated people said they would be more likely to get vaccinated with a shot that had been fully approved.
But pollsters and other experts warned that the percentage could be exaggerated. “I think that is a vanishingly small number of people in real life,” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania and expert on vaccine hesitancy.
Some experts have estimated that full approval might convince just 5% of those who are unvaccinated to get shots. If so, “that’s still a huge slice of people,” said Dr. Thomas Dobbs, the chief health officer for Mississippi.
In his remarks, Mr. Biden acknowledged that the death rate, now averaging about 1,000 new deaths a day, had climbed, but he said the toll was still far lower than what it was last winter because most older people had been vaccinated. He also tried to reassure anxious parents about the growing numbers of children who had been infected with the Delta variant, saying that severe Covid cases among children were still “very, very rare.”
The vaccine will continue to be authorized for emergency use for children 12 to 15 while Pfizer collects the data required for full approval. A decision on whether to authorize the vaccine for children under 12 could be at least several months away, and Dr. Woodcock said such children should not get a Covid-19 vaccine in the meantime.
So far, more than 92 million Americans — 54% of those who are fully inoculated — have gotten Pfizer shots. Most of the rest received Moderna’s vaccine.
Pfizer said it had presented the F.D.A. with data from 44,000 participants from clinical trials in United States, the European Union, Turkey, South Africa, and South America. The agency said the data showed the vaccine was 91% effective in preventing Covid disease, a slight drop from the 95% efficacy rate reported when the agency authorized the vaccine for emergency use in December.
Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said the agency had finished its review 97 days after Pfizer filed the required data, or about two-fifths the normal time for such an evaluation.
He said that while the F.D.A. had approved the vaccine “expeditiously,” it had done so “fully in keeping with our existing high standards for vaccines in the U.S.”
Federal health agencies will continue to monitor the vaccine’s safety, Dr. Marks said, and the F.D.A. will require Pfizer to keep studying the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including the long-term outcomes for recipients. In June, the F.D.A. attached warnings to the Pfizer-BioNTech and Moderna vaccines noting a potential for increased risk of the conditions after a second dose.
Health experts and state officials welcomed the approval. Dr. Richard Besser, the president of the Robert Wood Johnson Foundation and the former acting director of the Centers for Disease Control and Prevention, said it “could not come at a more important time,”
Vaccination rates have already been rising lately, likely in part because of growing fears about the Delta variant’s spread. Mr. Biden said that more people in Alabama, Arkansas, Louisiana and Mississippi — all states being ravaged by the Delta variant — had gotten first shots in the past month than in the previous two months combined.
The next major vaccine decision looming for the F.D.A. involves whether to authorize booster shots, which federal officials have strongly discouraged people from seeking until regulators decide they are safe and effective.
The Biden administration said last week that starting Sept. 20, pending regulatory approval, it planned to offer third shots to adults who had gotten their second injection of Pfizer and Moderna vaccines eight months earlier. Third shots are already authorized for some people with immune deficiencies.
Regulators are still reviewing Moderna’s application for full approval of its vaccine. That decision could take several weeks. Johnson & Johnson is expected to apply soon for full approval.
Source: NYTimes