2021-09-23 04:27:35 F.D.A. Authorizes Pfizer Booster Shot for Higher-Risk People

F.D.A. Authorizes Pfizer Booster Shot for Higher-Risk People

WASHINGTON (AP) — Following weeks of internal conflict at the FDA, the agency on Wednesday authorized people over the age of 65 who had received Pfizer-coronavirus BioNTech’s vaccine to receive a booster shot at least six months after their second injection.

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

The authorization establishes what will most likely be a staggered campaign to deliver the shots, beginning with the most vulnerable Americans. It paves the way for potentially tens of millions of previously immunized people to receive booster shots at pharmacies, health clinics, doctors’ offices, and other locations.

The acting FDA commissioner, Dr. Janet Woodcock, stated 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 had a lenient attitude toward the subgroups it deemed eligible for an additional injection.

According to the Centers for Disease Control and Prevention, approximately 22 million Americans have received their second dose of the Pfizer-BioNTech vaccine at least six months ago. Half of them are over the age of 65.

Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to find out if they can receive boosters. The Food and Drug Administration is expected to take up the issue of boosters for them soon.

The Food and Drug Administration’s decision will be followed by a recommendation from the Centers for Disease Control and Prevention, which provides vaccine policy guidance to clinicians and public health officials across the country. The CDC’s advisory committee is currently meeting for two days on the subject. Even if the C.D.C. takes a different stance, health-care providers are now permitted to provide third shots to Pfizer-BioNTech recipients who meet the F.D.A.’s eligibility criteria.

The decision came after weeks of internal conflict at the FDA, where some vaccine regulators openly opposed the idea of offering booster shots to the general public. Public health experts and state officials have criticized the Biden administration for sending out conflicting public messages about who should be eligible for a booster shot and when.

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

With Wednesday’s approval, the United States became the most recent wealthy nation to offer people booster doses, joining a list that includes Germany, France, Israel, and the United Kingdom. Some public health experts believe that those doses should instead be directed to countries with far fewer residents who have been vaccinated.

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

“We believe boosters will play an important role in addressing the disease’s ongoing threat, alongside efforts to increase global access and uptake among the unvaccinated,” said Albert Bourla, chairman and CEO of Pfizer.

Dr. Peter Marks, the FDA’s top vaccine regulator, described the need to provide boosters to Pfizer-BioNTech recipients aged 65 and older as a “no-brainer” in an interview.

However, the agency’s decision to include other population subgroups as eligible may spark a more heated debate.

It is unclear, for example, whether the C.D.C. will recommend booster shots for people considered at high risk because they work in health care, education, or retail, or because they live in homeless shelters or prisons, as the F.D.A. clearly favors.

When asked why Dr. Woodcock stated in her statement that those groups should be considered eligible for additional shots, Dr. Marks said it was important to identify examples of people who are at special risk due to their jobs or the institutions in which they live.

“What would your first question have been if she hadn’t put that there?” he wondered. “‘Who are you referring to?’”

Members of the agency’s expert advisory committee said last Friday that health care workers should be eligible for boosters because of their work.

The Food and Drug Administration’s decision to include those who are at high risk of severe Covid-19 captures yet another significant segment of the population. An estimated 60% of Americans have obesity or other chronic medical conditions that increase their risk of severe Covid-19, but not all of them may be included.

Pfizer had asked the FDA to approve a third shot for all vaccine recipients aged 16 and up, six months or more after their second injection. Regulators were scrambling to collect and review safety and efficacy data in time to meet the administration’s goal of offering shots this week.

During a dramatic meeting last week, members of the Food and Drug Administration’s outside advisory committee stated that the available data was insufficient to justify additional injections for so many people, and they 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 the C.D.C.’s experts raised repeatedly.

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F.D.A. Authorizes Pfizer Booster Shot for Higher-Risk People