The FDA plans to authorize Pfizer boosters for all adults this week

Washington — The Food and Drug Administration aims to approve a booster dose of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday. Agency planning.

An independent committee of vaccine experts at the Centers for Disease Control and Prevention will meet on Friday to discuss data on the efficacy and safety of booster doses. If both the FDA and the CDC approve this week, they will act surprisingly quickly — a little over a week. Pfizer asked For booster approval for everyone over 18 years old.

In that scenario, an adult who received a second vaccination at least 6 months ago is officially eligible for a booster this weekend. The FDA is expected to meet frequently during pandemics to review vaccine data and make decisions without consulting its own expert committee that makes recommendations prior to regulatory decisions.

Extensive booster approval has been seen for weeks as a observance of certain facts.Some state and local officials Started deploying a similar policy Prior to the FDA’s actions — the response to persistent viral cases, including some groundbreaking cases, and the enthusiasm of many Americans for additional protection before holiday gatherings.

New York City Health Authority On Monday, all adults who wanted boosters were encouraged to look for them. Arkansas, California, Colorado When New Mexico I also moved to expand access.

Many Americans have taken the problem into their hands and asked for additional doses, regardless of where they live, even if they are not yet officially qualified.

The September FDA reduced the initial request from Pfizer-BioNTech to fully approve booster doses for all adults. Instead, it qualifies a more limited population, including people over the age of 65, adults with an underlying disorder, or people at risk for work.

According to some estimates, at least 30-40 percent of vaccinated adults are still excluded from booster eligibility.

Over 30 million people We have already taken additional shots and the number of days is often higher than the number of shots initially given nationwide. Booster doses were also approved in October for all persons who received a single Johnson & Johnson vaccination and for a vulnerable group who received a double dose of Moderna.

The CDC rally on Friday will be shorter than the recent conference on the Covid vaccine. 3 hours.. A federal official familiar with the plan expects it to be easy, partly because the country’s booster campaign is already underway. This suggests that dissenting opinions among public health experts have eased significantly since President Biden announced in August that he wanted to provide boost immunity to all adults.

Biden wanted to launch the campaign in late September, but his announcement was strongly criticized by public health experts. Quickly Federal scientists and regulators responsible for determining whether data supports such movements.

Some key regulatory agencies and external advisors have specifically claimed the effectiveness of the double-dose regimen. Has held up strongly to prevent hospitalization and death..one Large-scale research In New York, nearly 9 million people have shown amazing durability in the protection gained from all three federally licensed vaccines.

But recently, some federal regulators and scientists have shown that reduced vaccine efficacy against mild Covid cases and protective antibodies put Americans, especially the elderly and those with medical conditions, at risk of harmful breakthrough infections. He states that more and more evidence is being exposed to the disease. Because the delta variant of the virus only gradually loosens its grip.

Pfizer and BioNTech said last week that their request was based on data from clinical trials in the United States and elsewhere, including more than 10,000 volunteers. After the third dose, they said the vaccine efficacy rate for symptomatic disease recovered to about 95%. However, it is unclear how long the protection from booster shots will last.

Moderna will soon submit its own request to the FDA to expand the eligibility of boosters. But for now, according to people familiar with the plan, with widespread approval, all adults can get a Pfizer booster.

Heads of federal health officials, including Dr. Anthony S. Fauci, often point to Israel, which launched a booster campaign in late July and is now offering additional shots to everyone over the age of 12. The United States is clear.Dr. Forch said in Reuters-sponsored event On Tuesday, if boosters were available to everyone, the virus could be under control in the United States by spring.

Vaccine experts say that antibody protection is only one measure of how vaccines provide protection, and that Covid vaccines were always expected to decline. Some warn that regular booster shots may be needed to keep antibody levels high. This is a difficult standard to maintain.

According to experts, the first dose to unvaccinated individuals who are promoting the transmission of the virus is more important than booster immunization.

The FDA’s expert committee is not expected to weight before the FDA’s ruling, but boosters said several members needed to move forward and lower their age qualifications at last month’s meeting. He said he had discussed the shot.

Israeli research published in the scientific journal The Lancet A comparison of approximately 730,000 individuals who received boosters in August or September in late October with individuals who received only two Pfizer-BioNTech vaccines at least five months ago received boosters. Recipients were found to have a lower risk of hospitalization and serious illness. ..

Israeli officials reported at an FDA meeting last month that the third dose did not raise serious safety concerns. Pfizer was expected to present to the FDA with a request for increased eligibility. At a CDC panel meeting on Friday, the company may consider the data it provides regarding side effects. Regulators are particularly concerned about the association between Pfizer-BioNTech and Moderna vaccines and myocarditis, especially myocarditis observed in young men who received two doses of these vaccines.

A. Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan and a member of the FDA Commission, was the first to clear a large number of adult booster shots, largely based on data from Israel. Was skeptical, but now more confident that millions of Americans have received additional shots.

“Attention is always better,” she said. She added that clearing more adults to get boosters would help make the message about booster shots easier to handle.

Dr. Ofer Levy, director of the Precision Vaccine Program at Harvard Children’s Hospital and a member of the FDA Advisory Board, said the US booster campaign so far has been “Helter Skelter.”

“Each of us has our own personal psychology, risk tolerance and belief system, and people are sometimes backed by data, sometimes backed by emotions and fears,” he said. Told.