FDA clears Pfizer booster shots for older, at-risk Americans

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

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

The clearance sets up what is likely to be a phased campaign to deliver the blows, starting with the most vulnerable Americans. It paves the way for tens of millions of people vaccinated to receive reminders in pharmacies, clinics, doctor’s offices and elsewhere.

According to the Centers for Disease Control and Prevention, about 22 million Americans have at least six months after their second dose of the Pfizer-BioNTech vaccine. About half of them are 65 and over. Millions of Americans who have received Moderna and Johnson & Johnson vaccines are still waiting to see if they too can receive boosters.

The FDA’s decision will be followed on Thursday by a recommendation from the CDC, which is issuing guidance on vaccine policy for clinicians and public health officials across the United States. A CDC advisory committee is now in the middle of a two-day meeting on the matter. But even though the CDC takes a different stance, healthcare providers are now allowed to offer third injections to Pfizer-BioNTech beneficiaries who meet FDA eligibility criteria.

The move follows weeks of internal disagreement 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 criticized what they said were confused public messages from the Biden administration on who should be eligible for a recall and when.

Regulators have significantly slowed the rollout of the reminder that senior federal health officials drafted and announced by President Biden in mid-August. At the time, Mr Biden said that, pending regulatory approval, he wanted to offer a third injection to every American adult who had been fully vaccinated with the Pfizer-BioNTech or Moderna vaccine at least eight months earlier, at starting this week.

But so far, the FDA has only cleared the booster injections for Pfizer-BioNTech beneficiaries, and not for all. Regulators are expected to decide whether or not to allow injections for Moderna and Johnson & Johnson vaccine recipients as soon as possible.

Wednesday’s clearance made the United States the last wealthy country to offer booster doses to people, 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 vaccinated far fewer of their residents.

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At a Covid-19 virtual summit on Wednesday, Mr Biden pledged 500 million additional doses of Pfizer-BioNTech vaccine to countries in need.

The FDA’s decision could spark a heated debate over who belongs to eligible subgroups, particularly those who are considered to be at particular risk because of their work.

At a meeting last Friday, members of the agency’s expert advisory committee said healthcare workers should be eligible for recalls because of their work, and a senior FDA regulator said stated that teachers belonged to the same category. There has also been pressure to include some inmates and staff in prisons and prisons due to the risks associated with incarceration. These specific recommendations will be left to the CDC

The FDA’s decision to include those who are at high risk for severe Covid-19 captures another significant swath in the population. It is estimated that 60% of Americans suffer from obesity or other chronic health conditions that increase their risk of suffering from severe Covid-19, but not all could be included.

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

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

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

The FDA not only restricted Pfizer’s request, but authorized the third shot as an emergency rather than fully approving it.

In practice, since the FDA fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, doctors have had a great deal of latitude in prescribing a third dose to people they deemed necessary. Many Americans have already requested additional injections on their own, usually by finding a cooperative pharmacist or pretending to be unvaccinated.

“There is anxiety about this public expectation that everyone should go for a recall,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, which represents the state health agencies. “If we back down on this, then the states are going to end up with the bag. “

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Former FDA chief scientist Dr Jesse L. Goodman said that due to some uncertainty over the benefits of boosters, regulators were correct in granting only emergency clearance for injections. while continuing to study their safety and performance.

“A phased approach makes a lot of sense,” he said.

Some state health officials have enthusiastically greeted the FDA’s decision. Dr Clay Marsh, West Virginia’s Covid-19 Tsar, said his state’s success in vaccinating older residents meant they were overdue for additional protection.

He also said overburdened hospitals in the state could not afford to lose more staff and that the booster doses could protect frontline workers from milder infections that would force them to stay at home.

“Anxious would be an understatement,” he said of those waiting for more hits. “We asked them to be patient with us. We have received texts and emails from people saying they are living like hermits again with the Delta variant, asking us when that would be safe.

The decision is the latest in a series of important decisions the FDA is expected to make in the coming weeks. To come complex decisions on whether to authorize booster injections for recipients of the Johnson & Johnson and Moderna vaccines, whether or not to authorize the use of Moderna’s vaccine for children aged 12 to 17 years, and Whether or not to authorize Pfizer-BioNTech’s vaccine for children aged 5 and 11.

Senior federal health officials have said they must publicly announce plans for a recall campaign so that states can prepare for a deployment. But some state officials said it was a challenge to sort through the 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 change had disrupted state planning and prompted authorities there to “scramble” to prepare for many more residents who may now be eligible.

“We thought that at eight months we were going to agree with supply and demand, our basic infrastructure being clinics and pharmacies. But if we have 350,000 eligible people at the start, we’re going to have challenges, ”he said, referring to state estimates. At least one county is now preparing to reopen a fairground site for booster doses, he said.