FDA Plans to Authorize Pfizer Boosters for All Adults This Week


WASHINGTON — The Food and Drug Administration aims to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults by Thursday; This is a move that will increase the number of Americans eligible for the supplement by tens of millions. agency plans.

The Centers for Disease Control and Prevention’s independent committee of vaccine experts scheduled a meeting Friday to discuss data on the efficacy and safety of the booster dose. If both the FDA and CDC sign the deal this week, they’ll have moved dramatically in just over a week. Pfizer asked For empowerment empowerment for anyone 18 years and older.

Under this scenario, any adult who received a second dose of vaccine at least six months ago will be officially eligible for support as soon as this weekend. The FDA is expected to make a decision without consulting its own panel of experts, which often meets during the pandemic to review vaccine data and make a recommendation before a regulatory decision.

Broad support authorization has been seen as a fait accompli for weeks. Some state and local authorities began to implement similar policies Prior to FDA action—responding to persistent virus case numbers, including some breakthrough cases, and the enthusiasm of many Americans to seek additional protection before their holiday gatherings.

New York health officials On Monday, she encouraged all adults who wanted a booster to seek them out. Arkansas, California, Colorado and New Mexico also moved to expand access.

Many Americans, regardless of where they live, have taken the matter into their own hands and sought extra doses even if they haven’t yet been formally qualified.

In September, the FDA reduced Pfizer-BioNTech’s initial request to fully approve booster doses for all adults. Instead, it made fit for a more limited population, including those aged 65 and over, as well as those with underlying medical conditions or those at risk from their jobs.

By some estimates, at least 30 to 40 percent of vaccinated adults are still excluded from supportive eligibility.

more than 30 million people They have already received additional shots, and the daily number often outstripped the number of first shots nationwide. Additional doses were also approved in October for anyone who received a single dose of Johnson & Johnson vaccine and for vulnerable groups who received two doses of Moderna’s vaccine.

The CDC’s meeting on Friday is scheduled to be shorter than recent meetings on COVID vaccines – only three hours. It’s expected to be simple, partly because of how far the nation’s support campaign has gone, said a federal official familiar with the planning. This indicates that opposition among public health experts has softened considerably since President Biden announced in August that he hopes to offer booster doses to all adults.

Mr Biden wanted to launch the campaign in late September, but his announcement was heavily criticized by public health experts, who said he was. rush federal scientists and regulators responsible for deciding whether data supports such a move.

Some key regulators and outside consultants agree that the two-dose regimen, especially strongly resisted in the prevention of hospitalization and death. A great work Nearly nine million people in New York showed remarkable resilience in protection from all three federally approved vaccines.

But more recently, federal regulators and scientists have said that the evidence is increasingly clear that a reduction in vaccine efficacy and protective antibodies against milder cases of Covid puts Americans—especially the elderly and those with medical conditions—at risk for harmful epidemic infections. The Delta variant of the virus only slowly loosens its grip.

Pfizer and BioNTech said last week that their claims were based on data from a clinical trial involving more than 10,000 volunteers in the United States and elsewhere. They said that after a third dose, the vaccine’s effectiveness rate against symptomatic disease reached about 95 percent. However, it remains unclear how long it will take to protect from a booster shot.

Moderna is expected to soon submit its own request for the FDA to expand eligibility for its booster. However, according to people familiar with the planning, for now any adult can get the Pfizer booster if they have broad authority.

Senior federal health officials, including Anthony S. Fauci, have debated for months — often citing Israel, which launched its support campaign in late July and now offers extra shots to anyone aged 12 and over — to raise the case widely. United States is open. Dr. fauci, An event sponsored by Reuters He said Tuesday that if boosters were available to everyone, the virus could potentially be contained in the US by spring.

Vaccine experts have said that antibody protection is only a measure of how a vaccine provides protection, and is always expected to be lost when it comes to Covid vaccines. Some have warned that keeping antibody levels high will likely require regular booster shots—a standard that’s hard to maintain.

While the FDA’s expert committee is not expected to weigh in before the agency’s decision, several members said at a meeting last month that the agency should go ahead and lower age eligibility.

An Israeli study published in the scientific journal The Lancet It compared nearly 730,000 people who received additional doses in late October, August, or September with those who had only received two doses of the Pfizer-BioNTech vaccine at least five months ago, and found that those who received the supplement had a lower risk of hospitalization and serious illness. . Those with booster vaccines were evaluated between one week and about two months after their third dose.

Israeli officials reported at an FDA meeting last month that the third doses did not raise any major safety concerns; This finding was expected by Pfizer to submit to the FDA in a request to extend compliance. At Friday’s CDC panel meeting, it will review the data the company has provided on side effects. Regulators are particularly concerned about links between the Pfizer-BioNTech and Moderna vaccines and myocarditis, an inflammation of the heart muscle observed in young men, particularly those who received two doses of these vaccines.

While initially skeptical about clearing booster vaccines for many adults based on data from Israel, A. Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan and a member of the FDA committee, is now more convinced that millions of Americans are getting the extra shots. it happened.

“It is always better to be careful,” he said. He added that purging more adults to get boosters will help make messaging about booster shots more manageable.



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