FDA authorizes coronavirus booster shots for all adults

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FDA authorizes coronavirus booster shots for all adults

WASHINGTON — The Food and Drug Administration on Friday authorized booster shots of both Pfizer-BioNTech and Moderna vaccines for everyone age 18 and older, opening up eligibility for millions more fully vaccinated adults.

Moderna and Pfizer both announced that regulators have broadened authorizations for their booster shots.

The move simplifies qualification, complements a pledge by President Biden to offer shots to every American adult and formally allows a practice already in place in at least 10 states. Fearing that decreased protections and the onset of winter would set off a wave of breakthrough infections, a growing number of governors offered boosters to everyone 18 and older even before the holidays.

The federal government’s top infectious disease expert, Dr. Anthony S. Fauci has argued consistently over the past month for booster shots for all adults, a position shared by Mr Biden’s other health advisers. Dr Fauci has said that the drop in antibody levels in fully vaccinated people was a clear indication that booster shots were needed. Public health experts who argue that healthy young adults do not need them, they have said, are ignoring the risks of symptomatic COVID-19.

“Enough is enough. Let’s go here,” He said at an event on Wednesday night, “We know what the data are.”

If the Centers for Disease Control and Prevention agrees, all adults who received a second shot from Pfizer or Moderna at least six months ago will be eligible for a booster shot by the weekend. A meeting of the agency’s external advisors is to be held on Friday.

At a White House briefing on Wednesday, CDC Director Dr. Rochelle Valensky promised that the agency will “review the safety and effectiveness data immediately and make recommendations as soon as we hear from the FDA.”

The FDA’s action comes after months of heated debate between the administration and the scientific community about who needs booster shots and when. Some outside advisers to the FDA and CDC repeatedly expressed discomfort with how quickly the administration was moving to offer the shots. Critics said the administration’s booster campaign was more motivated by practical or political reasons than for scientific ones, and that federal regulators were analyzing safety and efficacy data on the fly.

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“There isn’t evidence that a major rollout of boosters is really going to have that much of an impact on the pandemic,” said Ira M., a vaccine specialist and professor of biostatistics at the University of Florida. Longini Jr. said. He said the booster dose could increase one’s protection, at least temporarily, but would do little to stop the transmission of the virus, which is being operated by the unaffiliated. To a jittery public, he said, a booster shot may seem like a quick and easy way to keep the virus at bay. But he reiterated the administration’s own oft-stated position that persuading a non-vaccinated person to get the shot should be a top priority.

Other public health experts have argued that the government needs to give boosters to all adults to clear up the confusion. The complex eligibility rules, as well as the government’s recent decision to let people choose from all three vaccines for their boosters, have left the public somewhat upset, he says.

“This FDA decision is overdue,” said Dr. Elizabeth McNeely, director of the Center for Genetic Medicine at Northwestern University’s Feinberg School of Medicine.

“Many people have had trouble understanding whether they should get a booster,” she said in a statement. “The message is very clear – get a booster!”

Until now, people eligible for a booster included people 65 and older, residents of long-term care facilities, people with underlying medical conditions, and those whose job or institutional living conditions increased their risk.

All recipients of Johnson & Johnson’s one-shot vaccine have already been approved to receive a booster shot at least two months after their injection.

Jason L. Schwartz, an associate professor of health policy at the Yale School of Public Health, said the latest authorization “is a recognition that the current approach to booster recommendations just isn’t working.”

“It’s so confusing that I think the public has stressed the importance of boosters,” he said. “And the groups for which it’s really important to get boosters — older individuals, long-term care residents, people with medical conditions — aren’t getting boosters at the rates they need. It’s time for a reset.”

The booster rollout is expanding, even as public health experts are debating whether young, healthy adults need the extra protection. The argument is stronger for recipients of Pfizer’s vaccine than for recipients of Moderna, which has proven to be significantly more potent.

While some studies have found that the effectiveness of the Pfizer vaccine against infection and hospitalization decreases about four months after the second dose, Moderna’s effectiveness remains stable.

At the same time, regulators have been intrigued by data from the Nordic countries and elsewhere, suggesting that young male MODERN recipients may face an increased risk of myocarditis, or inflammation of the heart muscle — a side effect as well. Pfizer is associated with the vaccine. Scientists have said that the absolute risk is still very small, most cases are mild and resolve quickly and that COVID-19 can also trigger myocarditis.

Concerns about myocarditis are behind the FDA’s decision to authorize the vaccine for adolescents.

At the heart of the booster debate is the question of what vaccines should do. Critics of the administration’s policy argue that, despite somewhat declining safety, vaccines are still fulfilling their mission of preventing serious illness and hospitalization.

Booster advocates like Dr. Fauci say that vaccines should also protect against symptomatic disease, especially since some patients avoid hospitalization but suffer long-term consequences.

“I don’t know of any other vaccines that we only worry about keeping people out of hospitals,” Dr. Fauci said at a White House briefing on Wednesday. “I think it’s an important thing to prevent people from getting symptomatic diseases,” including young people.

In recent weeks, states have moved to allow booster shots for all adults, including Massachusetts, Rhode Island, Kansas, Kentucky, Maine, Vermont, Arkansas, California, Colorado and New Mexico.

Several other countries have taken the same approach, including Australia, Brazil, Canada, Germany, Hungary, Israel, Japan, Norway and Saudi Arabia. EU regulators have authorized a booster dose of both Moderna and Pfizer-BioEntech for all adults.

Kitty Bennett contributed research.

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