Federal Panel Opens New Campaign by Recommending Support Shots

[ad_1]

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

The decisions were taken by the CDC panel, the Vaccine Applications Advisory Committee, in a series of votes that scientists suffered over their choices. The recommendations revealed deep divisions between federal regulators and outside advisers on how to contain the virus in the pandemic for nearly two years.

Just a day ago, the Food and Drug Administration authorized booster shots for some frontline workers. But the CDC’s advisors disagreed that doses are needed by large numbers of healthy people.

The next step is the CDC’s director, Dr. Rochelle Walensky’s official recommendation. As is typically the case, the agency’s guidance may conflict with that of the FDA if it follows the guidance of the agency’s advisory committee.

An administration official said Xavier Becerra, secretary of health and human services, may eventually need to mediate between the two agencies.

Brown University School of Global Health dean Dr. Ashish Jha said, “There is some complexity here, because Dr. “Walensky was part of the White House announcement.” “I think he will feel some pressure for healthcare workers to allow it.”

Depending on what’s decided, the White House will likely begin promoting and enforcing a plan for supporting footage as soon as Friday. This would be in line with the administration’s previously announced plan to deliver additional doses the week of September 20.

Regardless of scientific reservations, millions are expected to seek supporting shots. In a recent survey, nearly three-quarters of vaccinated Americans said they would prefer the vaccine if doses were available.

State health departments generally follow the CDC’s recommendations, but many americans Even before the FDA’s authorization, they’ve typically been scrambling for boosters by finding a cooperative pharmacist or claiming they’re unvaccinated.

The CDC’s consultants acted on what they described as insufficient research – with considerable frustration – by pondering over conflicting data points that rarely point in one direction.

Eventually, the panel unanimously approved booster vaccines for adults over 65 and residents of long-term care facilities who would most clearly benefit.

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

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

Still, several experts on the CDC panel encouraged a mix-and-match strategy, saying they saw little reason not to offer a Pfizer-BioNTech booster to someone who was qualified but had received the J. & J. vaccine, for example. Some members have warned that firing lots of booster shots that are periodically available when authorized will tax an already loaded health system.

The CDC panel’s guidance followed weeks of internal disagreement and public debate between American health officials and consultants. In mid-August, President Biden announced plans for accelerators to become available, but scientists and regulators cautioned that there is little research into who can benefit and how doses should be distributed.

The FDA’s acting commissioner, Janet Woodcock, said Wednesday that the agency’s mandate “will allow booster doses in certain populations, such as healthcare workers, teachers, and day care personnel, grocery workers, and those in homeless shelters or prisons, among others.”

But some members of the committee said there was little evidence that vaccinated teachers or even health workers were at risk of repeated exposure to the virus. The decision reflected fears that such broad advice would effectively open the door to an all-adult support campaign.

A professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, Dr. “In my opinion, the committee thought it was the kind of hole a truck could get through,” Paul Offit told reporters. Online briefing on Thursday.

For two days, the panel grappled with the public’s expectations for Covid vaccines, the safety of third doses, and how a support program would affect nursing home residents. Some scientists noted that booster doses alone would not reverse the pandemic: Only vaccinating the unvaccinated could.

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

Counselors also grappled with the lack of clarity about the purpose of vaccines: Should it be to prevent all infections or to prevent serious illness and hospitalizations?

Many have suggested that booster doses can only do the latter and that trying to prevent all infections is impossible. Experts said this reasoning supports limiting who should take doses.

On Thursday, CDC scientists presented models showing that if booster doses were to slightly increase people’s protection against hospitalization, additional vaccines could prevent more than 2,000 hospitalizations for every million doses given.

However, it was unclear how long additional protection from a booster would last, raising the possibility that boosters would need to be given repeatedly.

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

Consultants also grappled with the practicality of approving a booster vaccine only for Pfizer-BioNTech recipients, when close to half of vaccinated Americans received the Moderna or J. & J. vaccines.

“I don’t see how we could say to people aged 65 and over this afternoon, ‘You are at risk of serious illness and death, but right now only half of you can protect yourself,'” he said. Sarah Long, MD, a pediatrician and infectious diseases specialist at Drexel University School of Medicine in Pennsylvania.

Committee members also expressed concern Thursday that some recommendations—especially allowing some young Americans to receive booster vaccines after assessment of individual risks—will mean that only the wealthy and educated will have access to additional vaccines.

Some experts seemed to suggest Wednesday that it might be better to stop offering any booster vaccines until recipients of all three vaccines qualify for them.

Moderna’s empowering authorization can arrive in a few days to weeks. The company has applied to the FDA for authorization for a booster shot that carries half the dose delivered in the first two shots, complicating the agency’s negotiations.

Some global health experts have criticized the Biden administration for giving booster shots before most of the world has yet received the first dose. But analysts noted that even as the United States distributes booster vaccines, there should still be a substantial surplus of vaccines this year, urging the government to ship the extra doses abroad.

Sheryl Stolberg contributed to the news from Washington.

[ad_2]

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *