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Federal panel recommends booster shots, opening new campaign against virus



An influential science group on Thursday opened a new front in the coronavirus campaign, recommending booster shots of the Pfizer-BioNTech Covid vaccine for a wide range of Americans, including tens of millions of seniors. But experts have refused to approve additional doses for healthcare workers, teachers and others who may be more exposed at work.

The decisions were made by the CDC’s panel, the Advisory Committee on Immunization Practices, in a series of votes, in which scientists agonized over their choices. The recommendations revealed deep divisions between federal regulators and outside advisers over how to contain the virus almost two years after the start of the pandemic.

Just a day earlier, the Food and Drug Administration cleared booster shots for some frontline workers. But CDC advisers disagreed that the doses were needed by so many healthy people.

The next step is for Dr. Rochelle Walensky, director of the CDC, to make a formal recommendation. If she follows the guidelines of the agency’s advisory committee, as is usually the case, the agency’s guidelines may conflict with those of the FDA.

An administration official said Xavier Becerra, the secretary for Health and Human Services, may ultimately have to mediate between the two agencies.

“There is a complexity here, because Dr Walensky was part of the White House announcement” on boosters, said Dr Ashish Jha, dean of the Brown University School of Global Health. “I think she’s going to feel some pressure to allow this for healthcare workers.”

Depending on what is decided, the White House is expected to start promoting and rolling out a recall plan as early as Friday. This would be in line with the administration’s previously announced plan to offer the additional doses the week of September 20.

Whatever the scientific reservations, millions of people should seek booster shots. In a recent poll, about three-quarters of Americans vaccinated said they would opt for a booster if the doses were available.

State health departments generally follow CDC recommendations. But many Americans were rushing for recalls even before FDA clearance, usually by finding a cooperative pharmacist or pretending to be unvaccinated.

CDC advisers acted on what they described – with considerable frustration – as limited research, reflecting on conflicting data points that rarely pointed in one direction.

Ultimately, the panel unanimously approved the booster shots for adults over 65 and residents of long-term care facilities, who will clearly benefit from them.

The committee also supported injections for people aged 50 to 64 with health conditions that put them at risk of severe Covid-19, as well as for people aged 18 to 49 with certain medical conditions, on the basis of an assessment of their individual needs.

Only Americans who have already received two doses of the Pfizer-BioNTech vaccine will be eligible for booster shots. The panel was not asked to judge whether people who received Moderna and Johnson & Johnson vaccines should receive the additional doses, which have not been cleared by the FDA.

Several CDC panel experts nonetheless advocated a mix-and-match strategy, saying they saw no reason not to offer a Pfizer-BioNTech booster to someone who was qualified but had received, for example, the J. & vaccine. J .. Some members warned that administering multiple rounds of booster shots, available periodically when authorized, would strain an already overburdened health care system.

The CDC panel’s advice followed weeks of internal disagreement and public debate between health officials and U.S. advisers. In mid-August, President Biden announced plans for a booster deployment, but scientists and regulators were quick to point out that there was little research on who could benefit and how the doses should be distributed.

Acting FDA Commissioner Janet Woodcock said on Wednesday that the agency’s authorization would allow booster doses “in certain populations such as health workers, teachers and child care workers, grocers and consumers. people living in homeless shelters or prisons, among others “.

But some committee members said there was little evidence to suggest that vaccinated teachers, and even healthcare workers, were at risk of repeated exposure to the virus. The decision reflected fears that such a broad recommendation effectively opens the doors to a recall campaign for all adults.

“I felt like the committee felt like it was some kind of hole you could drive a truck into,” Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the University of Pennsylvania, told reporters. FDA Vaccine Advisory Group. online briefing Thursday.

Over the two days, the panel wrestled with public expectations regarding Covid vaccines, the safety of third doses, and how a booster program would affect nursing home residents. Booster doses alone would not reverse the pandemic, some scientists noted: only vaccination of unvaccinated people would.

“We can move the needle a bit by giving people a booster dose,” said Dr. Helen Talbot, associate professor of medicine at Vanderbilt University. But, she added, “the hospitals are full because people are not vaccinated.”

Counselors have also struggled with a lack of clarity on the purpose of vaccines: should it be to prevent all infections, or to prevent serious illness and hospitalization?

Many have suggested that booster doses can only do the latter, and that trying to thwart all infections is impossible. This reasoning supported limiting who should receive the doses, the experts said.

Scientists at the CDC presented models on Thursday showing that if booster doses slightly increase people’s protection from hospitalization, the extra injections could prevent more than 2,000 hospitalizations for every million doses given.

But it was not clear how long the extra protection against a booster would last, suggesting that boosters would need to be given multiple times.

Boosters can reduce infections in nursing home residents, who are among those most at risk. Even so, cases in nursing homes will persist when community transmission is high, according to a modeling study presented at the meeting.

The advisers also looked at the practicalities of approving a recall for Pfizer-BioNTech beneficiaries alone, when nearly half of Americans vaccinated received the Moderna or J. & J vaccines.

“I just don’t understand how, later this afternoon, we can say to people 65 and over, ‘You are at risk of serious illness and death, but only half of you can protect yourself. right now, “” said Dr. Sarah Long, pediatrician and infectious disease expert at Drexel University College of Medicine in Pennsylvania.

Committee members also expressed concern on Thursday that some recommendations – particularly that some young Americans be allowed to receive booster shots after an individual risk assessment – would mean that only the wealthy and educated would have access to additional injections.

Some experts appeared to suggest on Wednesday that it might be best not to recommend boosters until recipients of all three vaccines can benefit from them.

Moderna’s recall authorization can arrive in a few days to a few weeks. The company asked the FDA for clearance of a booster carrying half the dose given in the first two injections, complicating the agency’s deliberations.

Some global health experts have criticized the Biden administration for pushing the booster shots when much of the world has yet to receive a first dose. But analysts noted that even if the United States distributes booster shots, there is still expected to be a sizable vaccine surplus this year, and they urged the government to start sending the extra doses overseas.

Sheryl Stolberg contributed reporting from Washington.



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