What FDA Approval Means For Covid Booster Shot Qualification In the US

As a practical matter, doctors have considerable latitude to prescribe boosters. And in many states - particularly where vaccination has flagged and lots of doses are available - pharmacies have provided boosters to whoever wants them. 

The FDA action, which will presumably be verified by the CDC, could impose some restrictions on this, but primarily in states where vaccination levels are already high. JL 

Noah Weiland and Sharon LaFraniere report in the New York Times:

Pfizer had asked the F.D.A. to approve a third shot for all recipients of its vaccine who were 16 and older, six months after their second injection. (But) the F.D.A. not only narrowed Pfizer’s request, but authorized the third shot on an emergency basis instead of fully approving it. As a practical matter, physicians have had broad latitude to prescribe a third dose to people they deemed in need of one. 22 million Americans are at least six months past their second dose. Half of them are 65 and older.

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 get a booster shot at least six months after their second injection.

The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming severely ill with Covid-19 or are at risk of serious complications from the disease due to frequent exposure to the coronavirus at their jobs.

The authorization sets up what is likely to be a staggered campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for possibly tens of millions of vaccinated people to receive boosters at pharmacies, health clinics, doctors’ offices and elsewhere.

Dr. Janet Woodcock, the acting F.D.A. commissioner, said that the authorization would allow for booster doses “in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.” Her statement suggested that agency leaders took a permissive view of the subgroups it deemed eligible for an extra injection.

Roughly 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 and older.

Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to learn whether they, too, can get boosters. The F.D.A. is expected to take up the question of boosters for them in short order.

The F.D.A.’s decision will be followed as soon as Thursday by a recommendation from the C.D.C., which issues guidance on vaccine policy for clinicians and public health officials throughout the United States. An advisory committee of the C.D.C. is now in the midst of a two-day meeting on the issue. But even if the C.D.C. takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the F.D.A.’s eligibility criteria.

The ruling followed weeks of internal disagreement at the F.D.A., 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 said were confusing public messages from the Biden administration about who should be eligible for a booster shot and when.

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

Wednesday’s authorization 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 vaccinated far fewer of their residents.

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

“We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” said Albert Bourla, the chairman and chief executive of Pfizer.

In an interview, Dr. Peter Marks, the F.D.A.’s top vaccine regulator, described the need to offer boosters to Pfizer-BioNTech recipients aged 65 or older as a “no-brainer.”

But the agency’s decision to specify other population subgroups as eligible could set off a more spirited debate.

It is unclear, for example, whether the C.D.C. will decide to recommend booster shots for people considered at high risk because they are health care workers, teachers or grocery store clerks, or because they live in homeless shelters or prisons, as the F.D.A. clearly favors. Asked why Dr. Woodcock said in her statement that those groups should be considered eligible for extra shots, Dr. Marks said it was important to identify examples of people who are at special risk because of their jobs or the institutions in which they live.

“If she hadn’t put that there, what would your first question have been?” he said. “‘Who are you talking about?’”

At a meeting last Friday, members of the agency’s advisory committee of experts said that health care workers should be eligible for boosters because of their work.

The F.D.A.’s decision to include those who are at high risk of severe Covid-19 captures another significant swath of the population. An estimated 60 percent of Americans suffer from obesity or other chronic medical conditions that heighten their risk of suffering from severe Covid-19, but not all of them might be included.

Pfizer had asked the F.D.A. to approve a third shot for all recipients of its vaccine who were 16 and older, six months or more after their second injection. Regulators scrambled to collect and review safety and efficacy data fast enough to meet the administration’s goal of offering shots this week.

At a dramatic meeting last week, members of the F.D.A.’s outside advisory committee said the available data was too limited to justify additional injections for so many people and voted 16 to 2 against approving Pfizer’s request. Some of the committee’s experts were concerned that Pfizer’s clinical trial results on boosters included only about 300 volunteers, a point that was brought up repeatedly by the C.D.C.’s experts. But the advisory committee voted unanimously for the narrower option reflected in the regulatory decision.
The F.D.A. not only narrowed Pfizer’s request, but authorized the third shot on an emergency basis instead of fully approving it.

As a practical matter, since the F.D.A. fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, physicians have had broad latitude to prescribe a third dose to people they deemed in need of one. Many Americans have already sought extra shots on their own, typically by finding a cooperative pharmacist or pretending to be unvaccinated.

“There’s anxiety about this public expectation that everyone should go get a booster,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies. “If we pull back on that, then states are going to get left holding the bag.”

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

“A stepwise approach is very judicious,” he said.

Some state health officials greeted the F.D.A.’s move enthusiastically. Dr. Clay Marsh, West Virginia’s Covid-19 czar, said that his state’s success vaccinating older residents early meant that they were overdue for extra protection.

He also said that 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.

“Anxious would be an understatement,” he said of those waiting for extra shots. “We’ve asked them to be patient with us. We’ve gotten texts and emails from people saying they’re living like hermits again with Delta variant, asking when is it going to be safe. 

The decision is the latest in a series of important ones that the F.D.A. is expected to make in the next few weeks. Ahead lie complex decisions on whether to authorize booster shots for recipients of the Johnson & Johnson and Moderna vaccines, whether to authorize the use of Moderna’s vaccine for children ages 12 to 17, and whether to authorize Pfizer-BioNTech’s vaccine for children between the ages of 5 and 11.

Top federal health officials have said they needed to publicly announce plans for a booster campaign so that states could prepare for a rollout. But some state officials said it was a challenge to sort out conflicting messages from federal officials.

For instance, the president said people should be eligible for a booster eight months after their second shot, but the F.D.A. set the interval at six months. Patrick Allen, the director of the Oregon Health Authority, said that the switch has thrown off the state’s planning and caused officials there to “scramble” to prepare for many more residents who now could be eligible.

“We thought at an eight month window we were going to be OK with supply and demand, with our core infrastructure being clinics and pharmacies. But if we have 350,000 people eligible at the beginning, we’re going to have some challenges,” he said, referencing estimates the state has made. At least one county is now preparing to reopen a fairgrounds site for booster doses, he said.