F.D.A. Authorizes Coronavirus Booster Shots for All Adults

WASHINGTON — The Food and Drug Administration on Friday authorized booster shots of both the Pfizer-BioNTech and Moderna vaccines for everyone 18 and older, opening up eligibility to tens of millions more fully vaccinated adults.

The move simplifies eligibility, fulfills a pledge by President Biden to offer the shots to every American adult and formally allows a practice already in place in at least 10 states. Fearful that waning protection and the onset of winter will set off a wave of breakthrough infections, a growing number of governors had already offered boosters to everyone 18 and older ahead of the holidays.

The agency said the expansion was justified by currently available clinical trial data as well as real-world evidence. In a statement, Dr. Peter Marks, who leads the F.D.A. division that regulates vaccines, added: “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”

Dr. Anthony S. Fauci, the federal government’s top infectious disease expert, has argued relentlessly over the past month for booster shots for all adults, a position shared by most of Mr. Biden’s other health advisers. Public health experts who argue that healthy younger adults do not need them, he has said, are ignoring the risks of symptomatic Covid-19.

“Enough is enough. Let’s get moving on here,” he said at an event Wednesday night. “We know what the data are.”

If the Centers for Disease Control and Prevention agrees, all adults who received a second shot of either Pfizer or Moderna at least six months ago will most likely be able to get a booster shot by the weekend. The agency’s outside advisers are meeting to discuss the issue at noon Friday and will hear from Pfizer, Moderna and C.D.C. staff. A vote is scheduled for 2:45 p.m.

At a White House briefing on Wednesday, Dr. Rochelle Walensky, the C.D.C. director, promised that the agency would “quickly review the safety and effectiveness data and make recommendations as soon as we hear from F.D.A.”

The F.D.A.’s action came after months of fierce debate within the administration and the scientific community about who needed booster shots, and when. As large studies showed protection from all three federally authorized vaccines holding strongly, some outside advisers to the F.D.A. and C.D.C. repeatedly expressed discomfort with how quickly the administration was moving to offer the shots.

While the F.D.A. has been evaluating booster data for months, it granted the companies’ requests with remarkable speed. Pfizer-BioNTech filed its request roughly 10 days ago, and Moderna announced Wednesday that it had applied but did not say when.

The agency said that it did not convene its independent vaccine advisory committee because the panel had already had discussed the use of booster shots extensively…

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