The Food and Drug Administration 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 will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations. Defense Secretary Lloyd J. Austin III will be sending guidelines to the country’s 1.4 million active duty service members mandating that they be vaccinated, the Pentagon announced on Monday.
The approval comes as the nation’s fight against the pandemic has intensified again, with the highly infectious Delta variant dramatically slowing the progress that the country had made over the first half of the year. The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans who are eligible for shots to get them.
President Biden is planning to commemorate it in a speech urging vaccination scheduled for 1:30 p.m. Eastern time on Monday afternoon. “If you’re not vaccinated yet, now is the time,” the president said on Twitter.
“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Pfizer said it presented the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine was 91 percent effective in preventing infection — a slight drop from the 95 percent efficacy rate that the data showed when the F.D.A. decided to authorize the vaccine for emergency use in December. Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected.
A recent poll by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, found that three of every 10 unvaccinated people said that they would be more likely to get vaccinated with a shot that had been fully approved.
But the pollsters and other experts warned that 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.
More important, Dr. Buttenheim said, would be the effect of requirements. “Mandates simplify things for people,” she said.
The regulatory action gives doctors more leeway to prescribe a third shot of the Pfizer vaccine to patients, but federal officials strongly discouraged people from seeking extra shots until regulators decide they are safe and effective. Pending regulatory clearance, the federal government plans to start offering booster shots for adults next month.
The vaccine will continue to be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval. A decision on whether to authorize the vaccine for children younger than 12 could be at least several months away, and Dr. Woodcock said no child that age should be given any Covid-19 vaccine because regulators lack safety data.
So far, more than 92 million Americans — 54 percent of those fully inoculated — have gotten Pfizer shots. Most of the rest received Moderna’s vaccine.
Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said that the Pfizer vaccine’s licensure followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is produced. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” he said.
He said that federal health agencies would continue to monitor the vaccine’s safety and that the F.D.A. would require Pfizer to continue to study 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. The F.D.A. in June attached warnings to the Pfizer-BioNTech and Moderna vaccines noting possible increased risk of those conditions after the second dose.
Although Pfizer is now free to market the drug under the name Comiraty, the company said only the federal government will distribute doses in the United States.
Health experts and state officials welcomed the development. With the Delta variant driving up caseloads across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, president of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention. He called on schools and businesses to require vaccination before allowing people to congregate indoors.
Less than two months after it appeared to have curbed the spread of the virus, United States is now averaging around 150,000 new cases a day and more than 90,000 hospitalized Covid-19 patients. An average of about 1,000 a day are dying of Covid-19 — a toll that federal health experts recently dismissed as highly unlikely, before the Delta variant fully took hold. Many children under 12 are also becoming infected.
Vaccination rates have also rising in recent weeks, in part because of more fear of the virus. Providers were administering about 837,000 shots a day, a substantial jump from earlier this summer.
Some experts have estimated that full approval might convince just five percent of those who are unvaccinated to get shots. Even if that’s so, “that’s still a huge slice of people,” Dr. Thomas Dobbs, the chief health officer for Mississippi, a state that is particularly hard hit by the Delta variant. He said licensure will help “shake loose this false assertion that the vaccines are an ‘experimental’ thing.”
Dr. Marks, the vaccine regulator, cited a series of other myths about the vaccines as a major impediment to fighting the pandemic, including false claims that the shots would cause infertility, foster rather than prevent Covid disease or had led to thousands of deaths. “Let me be clear. These claims are simply not true,” he said.
The F.D.A. is in the midst of a decision-making marathon related to coronavirus vaccines. The next major one looming for regulators is whether or not to authorize booster shots. The Biden administration said last week it plans to offer third shots to adults who got the Pfizer and Moderna vaccines eight months after their second injection, starting Sept. 20. Third shots are already authorized for some people with immune deficiencies, but the risk-benefit calculus is different for the general population.
Federal health officials said that both Pfizer-BioNTech and Moderna’s vaccines, which rely on similar technology, wane in potency over time. That trend, they said, is converging with the rise of the particularly dangerous Delta variant, making those who completed their vaccinations at the start of the year increasingly vulnerable to infection.
Some health experts have challenged the decision to recommend booster shots as premature, saying the data shows that the vaccines are holding up well against severe disease and hospitalization, including against the Delta variant. Boosters would only be warranted if the vaccines were failing to prevent hospitalizations with Covid-19, some of those experts have said.
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.
Helene Cooper contributed reporting.
Correction: Aug. 23, 2021An earlier version of this item misstated the name of the organization led by Dr. Richard Besser. It is the Robert Wood Johnson Foundation, not the Robert Wood Foundation.

Source: New York Times

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