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FDA authorizes Pfizer-BioNTech, Moderna boosters for all adults

Officials hope the signoff injects new urgency about the importance of the extra shots.

A woman receives a booster shot of Moderna's coronavirus vaccine. REUTERS/Arnd Wiegmann (Arnd Wiegmann/Reuters)
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Federal regulators on Friday authorized Pfizer-BioNTech and Moderna coronavirus vaccine boosters for all adults, a one-size-fits-all strategy designed to shore up Americans’ defenses against a tenacious virus and reduce confusion over guidelines that have varied based on people’s age, occupation and where they live.

The Food and Drug Administration cleared the boosters for people 18 and older who are at least six months past their second shot of the two-dose vaccines. The move reflects an urgent effort to encourage millions of Americans to get the boosters to bolster waning immunity heading into the winter holiday season when millions will travel to see friends and family. It’s also an attempt to put in place a coherent federal approach as about a dozen states move ahead on their own to grant broad access to boosters.

“I have heard from I don’t know how many states, ‘everything is confusing here, can you make it simpler?’" Peter Marks, director of the FDA center that regulates vaccines, said in an interview. “I think this is pretty simple now: If you are over 18, and you have been vaccinated … it is time to go get a booster. Doesn’t matter which one you get, go get a booster.”

Still, it’s an awkward moment for federal officials who have wrestled with the issue since summer and been leapfrogged by New York City and several states, including Louisiana, Maine and Colorado, that already endorsed widespread use of the extra shots to try to stave off a spike in cases.

“The states made the right decisions, but the optics are awful in appearing to go rogue and undermining the federal agencies,” said Peter Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine.

Top infectious-disease expert Anthony S. Fauci said on Nov. 16 it's possible for coronavirus to become endemic next year if the U.S. ramps up vaccination rates. (Video: Reuters)

The Center for Disease Control and Prevention’s outside experts are meeting Friday afternoon to give advice on how the boosters should be used. Several have expressed reservations in the past about recommending the shots for healthy young men because of rare cardiac side effects from the Pfizer-BioNtech and Moderna vaccines, but all have also stressed the need for greater simplicity in vaccine guidelines. After getting the recommendations, CDC Director Rochelle Walensky is expected to sign off on broader use of boosters, also on Friday.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Walensky said at a White House covid-19 briefing on Wednesday.

The new federal approach, many experts note, essentially ratifies what has been occurring on the ground; most people who have sought the shots have gotten them simply by telling pharmacists they are eligible. Even so, only about 37 percent of fully vaccinated people over 65, and 17 percent of all adults have gotten boosters, according to the CDC.

Marks said the agency took a close look at the potential risk of heart-related side effects, called myocarditis and pericarditis, in older male teenagers and young men. Updated information and analyses showed that the risks posed by the boosters were very low, he said, and were far outweighed by the potential benefits of preventing covid-19.

Nevertheless, he said, the agency noted in its Moderna fact sheet for health care providers that some studies show a potentially higher risk of the side effect after the second shot of Moderna compared with Pfizer-BioNTech. The FDA also noted a lower risk from the booster shot than from the initial vaccination. Some countries have restricted or barred the use of Moderna vaccine in younger men because of concerns about that side effect.

The action on booster shots means the Biden administration has come full circle since August, when President Biden and his top health aides announced plans to make boosters available to all adults beginning in late September. The administration backed off after receiving sharp criticism from many scientists and public health experts who said there was little evidence that young, healthy people needed the extra shot, especially because of the cardiac issue.

Rebuffed on its boosters-for-all strategy, the government ended up recommending Pfizer-BioNTech and Moderna boosters for people 65 and older and adults at higher risk of covid because of medical conditions or their jobs or living situations. Officials advised everyone who had received the single-shot Johnson & Johnson vaccine to get a booster after two months, reflecting the weaker protection afforded by that vaccine. Officials also endorsed “mixing and matching” vaccines, meaning, for example, that someone could get a Pfizer-BioNTech booster even if they initially received the Johnson & Johnson vaccine.

David Dowdy, an epidemiologist at Johns Hopkins, expressed skepticism that boosters would affect the course of the pandemic. “Whether that is going to have a major impact in terms of transmission, probably not,” he said. “A large fraction of transmission is still occurring from people who are not vaccinated.” Getting those people inoculated, he argued, should be the No. 1 priority.

Still, Dowdy backed giving all adults the option of getting extra doses. “The risk-benefit ratio is sufficiently favorable that if you want a booster, this is the time to do it, with cases going up,” he said.

Robert M. Wachter, professor and chairman of the department of medicine at the University of California at San Francisco, was more enthusiastic.

“The evidence is just crystal clear now that [vaccine] efficacy wanes for all infections” and that boosters can reduce breakthrough cases and vulnerability to long covid,” he said.

The changed booster strategy comes as cases are ticking up in the Midwest and many northern states. The rolling average of new cases per 100,000 residents rose 17 percent in the seven days that ended Wednesday, according to The Washington Post’s covid-19 tracker.

Since the summer, the evidence for boosters has become much stronger. Additional data from Israel and other sources has shown a substantial drop in vaccine effectiveness over time, while the booster’s safety record has remained strong. That has prompted many experts to reverse course and endorse the extra shots. The changing opinions have frustrated some inside the administration who believe the United States should have promoted boosters earlier.

“This was confused from the beginning,” said Hotez, adding that disagreement among scientists was part of the problem. “There were arguments and confusion about the goals of vaccination” — specifically on whether they were designed primarily to prevent hospitalization and death, or all infections. He believes it’s important to try to prevent all infections and thinks boosters will help.

The authorization of the Pfizer-BioNTech booster for all adults has been anticipated for weeks. The company’s request, submitted to the FDA earlier this month, was based on a 10,000-person clinical trial that showed the extra shots restored the effectiveness of the vaccine against symptomatic illness to 95 percent.

But the timing of the Moderna clearance, which is for a half-dose of its vaccine, took people by surprise. It was not until Wednesday that the company announced it had asked the FDA for booster authorization for all adults. A few months ago, the company provided the FDA with data on about 350 people who received an extra shot six months after being fully vaccinated. That study showed the booster restored antibody levels that had declined.

Jesse Goodman, a former chief scientist at the FDA who is a professor of medicine at Georgetown University, said he was not concerned the agency was using accelerated timelines to review the applications, but hoped that FDA staffers were able to dig into potential side effects in young men.

“Certainly, substantial new data takes more than a day to review,” he said, referring to Moderna’s last-minute application. But he said the company has probably been providing the FDA with information for some time.

Marks said the agency handled the Moderna application at the same time as the Pfizer-BioNTech partly to avoid additional confusion.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, has been a leader of the administration’s booster drive, arguing since this summer that he believes third shots for the Pfizer-BioNTech and Moderna vaccines are necessary for optimal protection.

A booster isn’t a luxury, a booster isn’t an add-on, and a booster is part of what the original regimen should be,” Fauci recently told Stat news.

— Lena H. Sun and Jacqueline Dupree contributed to this story.

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