Pfizer asks for authorization for adult boosters

Pfizer asks for authorization for adult boosters


Pfizer and BioNTech on Tuesday asked federal regulators to extend the authorization of their coronavirus booster shot to all adults, a move that could significantly expand the number of recipients eligible for booster shots.

The Food and Drug Administration is expected to grant the request, perhaps before Thanksgiving, according to people familiar with the situation. If so, all adults who are fully vaccinated with injections made by Pfizer-BioNTech, Moderna or Johnson & Johnson are all eligible for a Pfizer booster, the people said.

The federal government has been planning to expand the categories of people eligible for additional injections since the first booster injections were approved for emergency use in late September.

An advisory board of outside experts from the Food and Drug Administration voted in September against a request from Pfizer to offer injections to all adults who had received two injections of the vaccine.

Instead, the committee recommended emergency booster shots for those over 65 or at high risk for Covid-19 due to their medical condition or work. Those categories, later authorized for both the Pfizer-BioNTech and Moderna vaccines, were still broad enough to cover at least 60 percent of the population, government officials said.

Experts remain divided on whether booster injections are necessary for the rest of the population, with many arguing that the vaccines continue to provide robust protection against serious illness and hospitalization, especially for younger people with no underlying medical conditions. And there is near-unanimous agreement that vaccinating the roughly 60 million Americans ages 12 and older who haven’t even received their first injection should remain the government’s top priority.

For younger, healthy people, the benefits of a booster shot will be marginal, according to Dr. Eric Rubin, a member of the FDA advisory panel and an adjunct professor of immunology at Harvard TH Chan School of Public Health.

Still, some leading experts argue that the case for booster shots for the general population is stronger now than it was two months ago. dr. Anthony S. Fauci, the federal government’s chief infectious disease expert, said earlier this month that the latest data from Israel shows the country’s aggressive booster campaign has drastically reduced serious illnesses, hospitalizations and deaths.

The FDA has authority to change Pfizer-BioNTech’s current emergency use authorization and is not expected to reconvene its advisory panel.

President Biden said in August that he wanted all adults to be eligible for booster shots due to concerns that the vaccines’ protection against infection wanes over time. The government planned to roll out boosters in the third week of September but had to postpone it after regulators said they needed more time to analyze the data.

Currently, adult recipients of both the Pfizer-BioNTech and Moderna vaccines are eligible for a third injection six months after their second injection if they are at least 65 years old or considered particularly at risk.

All Johnson & Johnson recipients are eligible for a second booster injection. And adult recipients of all three vaccines get to choose which vaccine they prefer as booster injection.

According to the Centers for Disease Control and Prevention, nearly 25 million people have received additional injections to date, including those who qualify because of immune deficiencies. That’s about 14 percent of people who are fully vaccinated.

According to people familiar with the situation, Moderna is also expected to apply for an emergency booster dose extension soon. But experts have said the request may be more complicated due to concerns about rare cases of myocarditis, or inflammation of the heart muscle, especially in men under age 30 who have received two doses of Moderna’s vaccine.

Similar concerns have been raised about the Pfizer-BioNTech vaccine, but to a lesser extent. One possibility is that health officials agree to lower the age restriction for a Moderna booster, but not to 18.

At a press conference at the White House earlier this month, Dr. Fauci said new data shows “rather dramatic results” from Israel’s booster campaign with the Pfizer-BioNTech vaccine.

An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who had received a booster dose in August or September with those who had received only two doses at least five months earlier. The study included recipients aged 12 years and older; the median age was 52 years.

Compared to the two-dose recipients, the boosted recipients had a 93 percent lower risk of hospitalization, 92 percent lower risk of major illness and 81 percent lower risk of death, the study found. The boosted recipients were evaluated at least one week after their third dose.

dr. Rubin, a member of the FDA advisory committee, said Israeli booster data presented to the panel in September was mostly limited to people 60 and older. Israel’s more recent data is reassuring, he said, because “when they moved to younger groups, they really didn’t see any significant security signals.”

dr. Rubin also said that many Americans seem to get booster shots regardless of their official eligibility, so maintaining complicated eligibility categories may not work after all. “People vote with their feet,” he said.



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Rachel Meadows

Rachel Meadows

Trending topics news writer who enjoys cooking, walking her dog and travel.

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