FDA Authorizes Pfizer Booster Shots For Older And At-Risk Americans

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WASHINGTON — After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTech’s coronavirus vaccine to receive a booster shot at least six months after their second shot.

The FDA has also approved booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming seriously ill from Covid-19 or who are at risk of serious complications from the disease due to frequent exposure to the coronavirus at work.

The authorization kicks off a likely staggered campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for potentially tens of millions of vaccinated people to receive boosters in pharmacies, health clinics, doctors’ offices and elsewhere.

About 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention. About half of them are 65 years and older. Millions of Americans who have received the Moderna and Johnson & Johnson vaccines are still waiting to hear if they too can get boosters.

The FDA’s decision will be followed from Thursday by a recommendation from the CDC, which provides guidelines on vaccine policy for clinicians and public health officials in the United States. A CDC advisory committee is now holding a two-day meeting on the issue. But even if the CDC takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the FDA’s eligibility criteria.

The ruling followed weeks of internal controversy at the FDA, where some vaccine regulators openly challenged the idea of ​​offering booster shots to the general population. Public health experts and state officials have criticized what they believe were confusing public messages from the Biden administration about who should be eligible for a booster shot and when.

Regulators have significantly delayed the rollout of the booster drafted by top federal health officials that President Biden announced in mid-August. At the time, Mr. Biden said that starting this week, pending regulatory approval, he wanted to offer a third shot to any U.S. adult who had been fully vaccinated with the Pfizer-BioNTech or Moderna vaccine at least eight months previously.

But so far, the FDA has only approved booster shots for Pfizer-BioNTech recipients, and not all of them. Regulators are expected to assess shortly whether to approve injections for recipients of the Moderna and Johnson & Johnson vaccines.

Wednesday’s approval made the United States the most recent wealthy nation to offer people booster doses, joining a list that includes Germany, France, Israel and Britain. Some public health experts say those doses should instead be directed to countries that have far fewer of their residents vaccinated.

At a virtual Covid-19 summit on Wednesday, Mr. Biden promised 500 million additional doses of Pfizer-BioNTech’s vaccine to countries that need them.

The FDA’s ruling could spark a spirited debate about who falls into the eligible subgroups, especially those considered particularly high-risk because of their jobs.

At a meeting last Friday, members of the agency’s expert advisory committee said health professionals should be eligible for boosters because of their work, and a senior FDA regulator said teachers fit into the same category. There was also a push to include some inmates and staff in jails and prisons because of the risks associated with incarceration. Those specific recommendations are left to the CDC

The FDA’s decision to include those at high risk for severe Covid-19 captures another significant portion of the population. An estimated 60 percent of Americans are obese or have other chronic medical conditions that increase their risk of severe Covid-19, but not all may be included.

Pfizer had asked the FDA to approve a third injection for all vaccine recipients who were 16 years of age and older, six months or more after their second injection. Regulators rushed to collect and review safety and efficacy data quickly enough to meet the administration’s goal of offering shots this week.

At a dramatic meeting last week, members of the FDA’s external advisory committee said the data available was too limited to justify additional injections for so many people and voted 16 to 2 against approving Pfizer’s request. Some committee experts were concerned that the results of Pfizer’s clinical trial on boosters included only about 300 volunteers, a point repeatedly raised by the experts at the CDC.

But the advisory committee voted unanimously for the narrower option reflected in the regulatory decision.

The FDA not only limited Pfizer’s request, but approved the third injection on an emergency basis rather than approve it in full.

Since the FDA fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, doctors in practice have had ample leeway to prescribe a third dose to people they deemed necessary. Many Americans have already sought additional injections on their own, usually by finding a cooperative pharmacist or pretending not to be vaccinated.

“There is concern about this public expectation that everyone should get a booster,” said Dr. Marcus Plescia, the chief physician of the Association of State and Territorial Health Officials, which represents state health agencies. “If we pull back from that, states will be left with the bag.”

dr. Jesse L. Goodman, a former chief scientist at the FDA, said that because of some uncertainty about the benefits of boosters, regulators were right to only grant emergency clearance for the shots while continuing to study their safety and performance.

“A step-by-step approach is very sensible,” he said.

Some state health officials welcomed the FDA’s action enthusiastically. dr. Clay Marsh, the Covid-19 Czar of West Virginia, said the success of vaccinating older residents of his state early meant they were too late for additional protection.

He also said overstretched hospitals in the state couldn’t afford to lose more staff, and booster doses could protect frontline workers from milder infections that would require them to stay at home.

“Fearful would be an understatement,” he said of those waiting for additional shots. “We’ve asked them to be patient with us. We’ve been getting texts and emails from people saying they’re living like hermits again with the Delta variant, asking when it will be safe.”

The decision is the latest in a series of important ones the FDA is expected to make in the coming weeks. We face complex decisions about whether to authorize booster shots for recipients of the Johnson & Johnson and Moderna vaccines, whether to use Moderna’s vaccine for children ages 12 to 17, and whether to use the Pfizer-BioNTech vaccine for children. between the ages of 5 and 11.

Top federal health officials have said they should publicly announce plans for a booster campaign so states could prepare for a rollout. But some state officials said it was challenging to resolve conflicting messages from federal officials.

For example, the president said people should be eligible for a booster eight months after their second injection, but the FDA set the interval at six months. Patrick Allen, the director of the Oregon Health Authority, said the switchover has messed up the state’s planning and forced officials there to “clamber up” to prepare for many more residents who would now qualify. can come.

“We thought that with eight months we would be in order with supply and demand, with clinics and pharmacies as core infrastructure. But if we have 350,000 people who qualify at the beginning, we will have some challenges,” he said. citing estimates made by the state, at least one county is now preparing to reopen a fairground for booster doses, he said.

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