FDA Vaccine Advisers OK Pfizer Booster For People Over 65 But Reject For Rest

CNBC: FDA Panel Recommends Pfizer's Covid Booster Doses For People 65 And Older After Rejecting Third Shots For General Population
An influential Food and Drug Administration advisory committee on Friday resoundingly rejected a proposal to distribute booster shots of Pfizer’s and BioNTech’s Covid-19 vaccine to the general public, paring back those plans to instead recommend the third shots to people age 65 and older and other vulnerable Americans. “It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital. (Lovelace Jr., Towey and Mendez, 9/17)

AP: US Panel Backs COVID-19 Boosters Only For Elderly, High-Risk
In a surprising turn, the panel rejected, by a vote of 16-2, boosters for almost everyone. Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups. Then, in an 18-0 vote, it endorsed the extra shot for select portions of the U.S. population — namely, those most at risk from the virus. (Perrone and Neergaard, 9/17)

Stat: FDA Advisory Panel Recommends Booster Doses Of Covid-19 Vaccine Only For Older And High-Risk Americans
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)

The Wall Street Journal: FDA Advisory Panel Endorses Covid-19 Boosters For People 65-Plus Or At High Risk Of Severe Illness
The vote followed a daylong meeting that included intense debate among committee members over who should receive boosters and when, and presentations that offered varying conclusions about declining vaccine effectiveness and the benefit of administering extra shots. Many panel members said they had concerns about widening booster shots for the general population with limited data about whether the additional doses would be safe and effective. Members said they would potentially support recommending a third dose for certain high-risk groups of the population such as older adults, but that there wasn’t enough data to justify giving it to the general population. They said that vaccines such as Pfizer’s are holding up against severe disease. (Hopkins and Schwarz, 9/17)

NPR: FDA Expert Panel Supports Pfizer COVID Booster For Older People
FDA then polled the panel members for advice on other groups of people who might be considered for a booster. Though not an official vote, the panel member unanimously supported authorization of a Pfizer booster dose for health care workers or others at high risk of occupational COVID-19 exposure. ... The administration said in August that it planned to make booster shots available during the week of Sept. 20. That announcement was controversial because it came before the FDA had weighed Pfizer's application and before the Centers for Disease Control and Prevention's own panel of experts on immunization practices could consider the need for boosters. (Hensley, 9/17)

Politico: FDA Panel Votes Against Broad Rollout Of Pfizer Booster Shot, Endorses Narrower Use
A separate Centers for Disease Control and Prevention panel will meet next week to outline the parameters for the booster's administration, which will likely include defining who qualifies as "high risk." That could include people with underlying health conditions like obesity, and groups like health care workers who are exposed to Covid-19 during the course of their jobs. The FDA panel took an unofficial straw poll Friday endorsing boosters for the latter group. (Gardner, 9/17)

And a new Israeli study shows good immune response from the booster shot —

CIDRAP: Studies Show Good COVID Booster Effect, Waning 2nd-Dose Protection 
Several new studies on the Pfizer/BioNTech mRNA COVID-19 vaccine describe good effectiveness against the Delta (B1617.2) variant after a booster dose and high but waning protection against infection and severe illness 6 months after the second dose. Other, much smaller, studies demonstrated the safety of third mRNA vaccine doses. And a new British study on waning two-dose effectiveness coincides with the recent decision by UK officials to recommend booster doses. (Van Beusekom, 9/16)

Also —

CNN: Do Americans Need Boosters Yet? Here Are The Questions The FDA Will Be Asking 
Vaccine advisers to the US Food and Drug Administration start meeting early Friday to discuss whether Americans need booster shots yet. It's a simple question but one that has become bogged down in politics and turf battles. It's sometimes seemed to put the FDA's independence at odds with a White House team eager to appear to be out ahead of an unpredictable pandemic. (Fox, 9/16)

CNBC: Booster Debate: Covid Vaccine Not Meant To Prevent Infection, Symptoms
Over the past week, there’s been plenty of back-and-forth among experts about whether people need Covid booster shots — but one crucial element is getting lost in the conversation. If you’re on team booster shot or not, or if you don’t know what to think, remember this: Being fully vaccinated is still preventing hospitalization in 86% of patients and death in 82%, according to the Centers for Disease Control and Prevention. In other words, even amid the spread of the contagious delta variant, the Covid vaccines are doing exactly what they’re designed to do. (Stieg, 9/16)

The Baltimore Sun: Who Gets A COVID-19 Vaccine Booster? For Now It Depends On Where You Live 
When Gov. Larry Hogan ordered COVID-19 boosters for some Marylanders earlier this month, he made the shots available for more people than elsewhere in the nation but didn’t go as far as some other countries. The Maryland order specifically said the doses should be available to residents in assisted living facilities, drug treatment centers and group homes for those with developmental disabilities. (Cohn, 9/16)