FDA advisory panel rejects widespread Pfizer booster shots
A U.S. Food and Drug Administration advisory committee on Friday voted to reject COVID-19 vaccine booster shots for most Americans, but authorized them for people 65 and over and those who are at high risk for severe COVID-19.
The votes came amid division among scientists inside and outside the FDA as to whether booster shots are necessary for people who are not immunocompromised, and who should receive them.
The vote against boosters of the Pfizer-BioNTech vaccine for anyone 16 and older who had received two earlier shots was 16-2. The FDA doesn’t have to follow the committee’s recommendation, but it usually does.
Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Medicine, called the decision "the perfect compromise. That’s exactly what needed to happen."
People 65 and older in general have waning antibody protection to all vaccines and would be among those most in need of a booster, especially because they are more likely to get seriously ill from COVID-19, she said.
Nachman said deciding who under 65 is at enough risk for severe COVID-19 to get a booster shot "is more subject to interpretation." She recommended that people with health conditions linked to severe COVID-19 should talk with their doctors about whether to receive a booster shot.
A Centers for Disease Control and Prevention committee next week is scheduled to discuss issuing more detailed guidance on who should receive a booster shot, including who would be considered at-risk for severe COVID-19.
Separate FDA and CDC decisions will be needed in order for people who received the Moderna or Johnson & Johnson shots to get boosters.
Members of the FDA panel of outside experts unanimously clarified that they believe "health care workers or others at high risk for occupational exposure be included" among those authorized to received boosters.
Dr. Betty Diamond, director of the Institute of Molecular Medicine at the Feinstein Institutes for Medical Research in Manhasset, said it makes sense to allow boosters for people who are most likely to be exposed to the coronavirus in the workplace.
"If you have something that’s not 100% efficacious, one of the variables that will influence your risk of getting disease is exposure," she said. "Health care workers, bus drivers, people who are exposed all the time to people who either have COVID or might be carriers of COVID, it’s reasonable to protect them."
Diamond said the committee’s overall decision was "a judgment call. It’s a risk-benefit calculation. It is not unreasonable. We know the vaccine‘s efficacy decreases over time, but we also know it’s good at keeping people from dying and from hospitalization. It makes sense that if there is a group that isn’t … at particular risk and are likely to still have good protection from the vaccine, it’s reasonable they don’t need" a booster.
Those people could later be authorized to receive boosters, she said. By that time, there also would be more safety data on booster shots, Diamond said.
Dr. Steven Carsons, director of the vaccine center at NYU Langone Hospital-Long Island in Mineola, said he "probably would have leaned more toward" allowing booster shots for anyone 16 and older.
Even healthy "younger people can get seriously ill from COVID and can be susceptible to complications from COVID, including long COVID," he said, referring to how many people continue to have COVID-19 symptoms — in some cases debilitating ones — many months after infection. Scientists don’t know if those long-term COVID-19 effects will be lifelong.
But, Carsons said, he understood why the committee chose to, for now, authorize booster shots only for higher-risk groups. "Reasonable people following the science can come to different conclusions," he said.
The FDA panel's rejection came despite full-throated arguments about the need for boosters from both Pfizer-BioNTech and health officials from Israel, which began offering boosters to its citizens in July.
Over several hours of discussion, committee members voiced frustration that Pfizer-BioNTech had provided little data on the safety of extra doses. Panel members also complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.
Research suggests that immunity levels in those who have been vaccinated wane over time and boosters can reverse that, but they also show the Pfizer-BioNTech vaccine is still highly protective against severe illness and death.
President Joe Biden’s top health advisers, including the heads of the FDA and CDC, announced plans for widespread booster shots a month ago, targeting the week of Sept. 20 as a start date. It said boosters would be dispensed eight months after the second dose of the Pfizer-BioNTech and Moderna vaccines.
But that was before FDA staff scientists had completed their own assessments of the data. Biden administration officials later said they would follow scientists' recommendations.
BOCES dealing with masking for special needs kids
Meanwhile, Robert R. Dillon, district superintendent for Nassau BOCES, told a Newsday LIVE webinar on Friday that school personnel are having to address developmental problems stemming from face-masking, particularly with special needs children.
"There are issues with not picking up the cues, the facial cues, that we’re dealing with now," he said. "We weren’t used to that. We’re becoming used to that. We will grow better with it. Particularly, we were concerned in the area of special needs children with speech and language development: A major part of that is the recognition and looking at the face and identifying the movements of the lips and the cheeks and all of that, so, you know, we have special masks for that — we have masks that are clear masks for that."
Dillon said most kids like wearing masks — "it’s the cool thing to do" when most peers are masking — and "for the most part, we’re not seeing the pushback from our students. The pushback comes in the home, and that’s where the challenge is right now."
Nachman said parents should be sure to get a mask that fits the child — and adult masks don’t.
For special needs children or adults, "They often will not want to wear a mask," she said.
In statistics released by the state Friday, Long Island’s seven-day average for positivity in tests for COVID-19 fell below 4%, registering at 3.97%. New York State’s seven-day average was 3.09%.Long Island registered 1,179 new daily cases of COVID-19 Thursday, according to test results released Friday. Nassau County logged 477, while Suffolk came in at 595. On Thursday, five Long Islanders died due to COVID-19, the state reported, with three in Nassau and two in Suffolk.
With Matthew Chayes, AP
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David Olson covers health care. He has worked at Newsday since 2015 and previously covered immigration, multicultural issues and religion at The Press-Enterprise in Southern California.
