Morning Briefing
Summaries of health policy coverage from major news organizations
FDA To Weigh Panel's Advice To Limit Boosters To Older Or High-Risk People
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 鈥渇ollow the science,鈥 Biden found himself uncharacteristically ahead of it with that lofty pronouncement. Some of the nation鈥檚 top medical advisers on Friday delivered a stinging rebuke of the idea, in essence telling the White House: not so fast. (Miller, 9/18)
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)
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 鈥 a major rebuke to the Biden administration 鈥 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 鈥
Dr. Anthony Fauci defended the Food and Drug Administration panel鈥檚 decision to reject offering a third booster shot of the Pfizer-BioNTech Covid-19 vaccine to the general U.S. population.聽鈥淚 don鈥檛 think they made a mistake,鈥 the White House chief medical adviser told CNN鈥檚 鈥淪tate of the Union鈥 on Sunday. Fauci added that he would support a third dose if future data shows it鈥檚 effective. As the FDA continues to gather new information on boosters, convincing unvaccinated Americans to get vaccinated remains the priority. (Subin, 9/19)
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)
The combination of aggressive state action and health experts鈥 pushback against Biden鈥檚 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)