FDA Authorizes Pfizer Booster Shot for High-Risk People

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

The FDA has also authorized booster vaccines for adult Pfizer-BioNTech recipients who are at high risk of becoming seriously ill with Covid-19 or who are at risk of serious complications from the disease because they are frequently exposed to the coronavirus at work.

The authorization creates a staggered campaign, likely to carry out the shootings, starting with the most vulnerable Americans. It’s probably paving the way for tens of millions of vaccinated people to take supplements in pharmacies, health clinics, doctor’s offices, and elsewhere.

According to the Centers for Disease Control and Prevention, nearly 22 million Americans have had at least six months since their second dose of the Pfizer-BioNTech vaccine. About half of them are 65 years or older. Millions of Americans who receive the Moderna and Johnson & Johnson vaccines are still waiting to find out if they can get the vaccine themselves.

The FDA’s decision will be followed as soon as Thursday by a recommendation from the CDC, which is issuing guidance on vaccine policy for clinicians and public health officials across the US. An advisory committee of the CDC is currently two-day meeting on the subject. But even if the CDC takes a different stance, healthcare providers now have the authority to offer third-party vaccines to Pfizer-BioNTech recipients who meet the FDA’s eligibility criteria.

The decision followed weeks of internal dispute at the FDA by some vaccine regulators. openly challenged the idea of ​​offering booster shots to the general population. Public health experts and government officials have criticized what the Biden administration says has been confusing public messages about who should be eligible for the vaccine and when.

Regulators have significantly slowed the delivery of support prepared by senior federal health officials and President Biden announced in mid-August. At the time, Mr Biden said he would like to offer the third vaccine to every American adult who was fully vaccinated with the Pfizer-BioNTech or Moderna vaccine at least eight months ago, starting this week, pending regulatory approval.

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

Wednesday’s authorization made the United States the latest wealthy country to offer people booster doses, joining a list that includes Germany, France, Israel and the United Kingdom. Some public health experts say these doses should instead be diverted to countries that have had much less of their residents vaccinated.

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

The FDA’s decision could spark a heated debate about who falls into the appropriate subgroups, especially those whose jobs are deemed to be at special risk.

At a meeting last Friday, members of the agency’s advisory board of experts said healthcare professionals should be eligible to take supplements because of their work, and a senior FDA regulator said teachers fit into the same category. There was also pressure to include some inmates and staff in prisons and prisons because of the risks of incarceration. These specific recommendations will be left to the CDC.

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

Pfizer had asked the FDA to approve a third vaccine for all vaccine recipients aged 16 years or older, six months or more after the second injection. Regulators have struggled to collect and review safety and efficacy data quickly enough to meet the administration’s goal of recommending the vaccine this week.

At a dramatic meeting last week, members of the FDA’s external advisory committee said the available data were too limited for many people to justify additional injections, and 2 to 16 votes against Pfizer’s approval to request. Some of the committee’s experts were concerned that Pfizer’s clinical trial results for boosters included only about 300 volunteers; this has been brought up again and again by CDC experts.

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

Not only did the FDA narrow down Pfizer’s claim, it also allowed a third shot in an emergency rather than fully approve it.

As a practical matter, since the FDA fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, doctors have had wide latitude to prescribe a third dose to those they think need it. Many Americans have already asked for extra shots on their own, typically by finding a cooperative pharmacist or pretending not to be vaccinated.

The chief medical officer of the Association of State and Regional Medical Officers, representing state health institutions, Dr. “There are concerns about this public expectation that everyone should get a boost,” Marcus Plescia said. “If we give up on that, then the states will stop holding the bag.”

A former chief scientist at the FDA, Dr. Jesse L. Goodman said that due to some uncertainty about the benefits of boosters, regulators were justified in issuing only emergency clearance for shots while continuing to review their safety and performance.

“A step-by-step approach makes a lot of sense,” he said.

Some state health officials enthusiastically welcomed the FDA’s move. West Virginia’s Covid-19 czar, Dr. Clay Marsh said his state’s success in vaccinating elderly residents early means they’re delayed for extra protection.

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

“It’s not enough to be anxious,” he said of those expecting extra shots. “We asked them to be patient with us. We have received texts and emails from people saying they are living like monks again with the Delta variant and asking when it will be safe.”

The decision is the latest in a series of key decisions the FDA is expected to make over the next few weeks. There are complex decisions about whether to allow booster vaccines for recipients of Johnson & Johnson and Moderna vaccines, whether to allow the Moderna vaccine to be used for children ages 12 to 17, and whether to approve Pfizer-BioNTech’s vaccine for children ages 12 to 17. 5 and 11.

Top federal health officials have said states must publicly announce their plans for a support campaign so they can prepare for launch. But some state officials said it was difficult to resolve conflicting messages from federal officials.

For example, the president said people should be eligible for a booster eight months after their second shot, but the FDA has set the range to be six months. Patrick Allen, director of the Oregon Health Authority, said the change upset the state’s planning and caused officials there to “counteract” to prepare for more residents who may now be eligible.

“Within an eight-month window, we thought we would be fine with supply and demand, where our core infrastructure is clinics and pharmacies. But if we have 350,000 eligible people at the start, we will face some challenges,” he said, referring to government estimates. At least one county is currently preparing to reopen a fairground for booster doses, he said.