FDA To Weigh Panel’s Advice To Limit Boosters To Older Or High-Risk People

AP: Top Doctors Say Not So Fast To Biden's Boosters-For-All Plan
Just one month ago, President Joe Biden and his health advisers announced big plans to soon deliver a booster shot of the coronavirus vaccine to all Americans. But after campaigning for the White House on a pledge to “follow the science,” Biden found himself uncharacteristically ahead of it with that lofty pronouncement. Some of the nation’s top medical advisers on Friday delivered a stinging rebuke of the idea, in essence telling the White House: not so fast. (Miller, 9/18)

NPR: FDA Panel Says Pfizer COVID Booster OK For Older People And Those At High Risk
In a surprising vote, a panel of advisers to the Food and Drug Administration on Friday recommended against approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people 16 years and older. The 16-2 vote against broad use of the booster, which would be given about six months after completion of the two-dose immunization regimen, dealt a setback to Pfizer and complicates the FDA's approach to boosters. After a brief intermission following the rejection, FDA officials returned to the meeting with a revised booster question. The panel then voted 18-0 in support of the agency authorizing a booster shot of the vaccine for people 65 and older or at high risk of severe COVID-19. (Hensley, 9/17)

Stat: FDA Advisory Panel Recommends Booster Doses Of Covid-19 Vaccine Only For Older And High-Risk Americans
An advisory panel to the Food and Drug Administration on Friday recommended against a booster dose of a Covid-19 vaccine for most Americans at this time — a major rebuke to the Biden administration — but voted unanimously to recommend one to Americans who are 65 or older. The FDA is not required to follow the recommendation of its advisory committees but generally does. If the recommendation is adopted by the FDA and Centers for Disease Control and Prevention, it would put the U.S. policy on a par with countries like the United Kingdom. (Branswell and Herper, 9/17)

Officials and lawmakers react to the panel's votes —

CNBC: Fauci Defends FDA Panel Decision To Reject Third Doses For All Americans
Dr. Anthony Fauci defended the Food and Drug Administration panel’s decision to reject offering a third booster shot of the Pfizer-BioNTech Covid-19 vaccine to the general U.S. population. “I don’t think they made a mistake,” the White House chief medical adviser told CNN’s “State of the Union” on Sunday. Fauci added that he would support a third dose if future data shows it’s effective. As the FDA continues to gather new information on boosters, convincing unvaccinated Americans to get vaccinated remains the priority. (Subin, 9/19)

Politico: Collins, Fauci Endorse And Explain FDA’s Recommendation For Limited Use Of Boosters 
U.S. health officials supported the recommendation from the FDA advisory panel that booster vaccines be limited to those 65 years and older and individuals at high risk for severe disease despite the expectation that the additional shots would be suggested for everyone who received the initial vaccination. National Institutes of Health Director Francis Collins said Sunday that the guidance issued Friday by the Food and Drug Administration is in line with what the Biden administration planned for a booster rollout, though not identical. (Crummy, 9/19)

Politico: Confusion Over Biden's Booster Plan Riles Governors
The combination of aggressive state action and health experts’ pushback against Biden’s plan has amplified confusion about who needs boosters now, as the highly contagious Delta variant rips across the country. Some doctors are already recommending or administering boosters to patients outside of the small group of severely immunocompromised people who already qualify for the shots. (Gardner, 9/19)