F.D.A. Plans to Authorize Pfizer-BioNTech Boosters as Soon as Thursday
The move would expand the number of Americans eligible for additional shots by tens of millions.,
The F.D.A. plans to authorize Pfizer-BioNTech boosters as soon as Thursday.
Booster shots of Pfizer-BioNTech’s coronavirus vaccine were on offer in Chelsea, Mass., last week.Credit…Brian Snyder/Reuters
WASHINGTON — The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.
The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.
Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The F.D.A. is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.
Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. But for now, every adult could get the Pfizer booster, according to people familiar with the planning.
The broad booster authorization has been viewed as something of a fait accompli for weeks. Some state and local officials have begun rolling out similar policies ahead of F.D.A. action — responding to persistent virus case counts and the eagerness of many Americans to seek additional protection ahead of holiday gatherings.
Many Americans, regardless of where they live, have taken the matter into their own hands and sought out extra doses even if they do not officially qualify yet.
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The F.D.A. in September downsized Pfizer-BioNTech’s request to fully approve booster doses for all adults, instead signing off on a more limited population, including those 65 and older, as well as adults with underlying medical conditions or those at risk because of their jobs.
At least 30 to 40 percent of vaccinated adults are still excluded from booster eligibility, according to some estimates.
More than 30 million people have gotten additional shots, with the number often outpacing the number of first shots given each day around the country. Booster doses were also authorized in October for everyone who received the single-dose Johnson & Johnson vaccine, and for vulnerable groups who received Moderna’s two-dose shot.
The C.D.C.’s gathering on Friday is scheduled to be briefer than recent meetings about Covid vaccines, just three hours, and is expected to be straightforward, one federal official familiar with the planning said, in part because of how far the nation’s booster campaign has already come. That would suggest a significant softening of opposition among public health experts since President Biden announced in August that he hoped to offer booster doses to all adults.
Mr. Biden wanted to start the campaign in late September, but his announcement was heavily criticized by public health experts, who said he was rushing federal scientists and regulators who had to decide whether the data supported such a move. Members of the F.D.A. and C.D.C. advisory committees have said they were uncomfortable with how quickly the administration wanted to offer booster shots to a large swath of Americans.
Some key regulators and outside advisers had been hesitant to endorse a sweeping booster campaign this early, arguing that effectiveness of the two-dose regimen, especially in preventing hospitalization and death, has held up strongly. One large study in New York of nearly nine million people has shown remarkable durability in the protection gained from all three federally authorized vaccines.
But more recently, federal regulators and scientists have said the evidence is increasingly clear that a reduction in vaccine efficacy against milder Covid cases, and in protective antibodies, has put Americans — especially seniors and those with medical conditions — at risk of harmful breakthrough infections as the Delta variant of the virus only gradually loosens its grip.
“Antibodies decay with time. That’s not just a coronavirus vaccine story,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the F.D.A. advisory committee. “Vaccines vary in the durability of the protective response. We are starting to see waning in other age groups as well.”
An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who had received a booster dose in August or September with individuals who had received only two doses of the Pfizer-BioNTech vaccine at least five months earlier, finding that boosted recipients had a lower risk of hospitalization and severe disease. Those with booster shots were evaluated between one week and nearly two months after their third dose.