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States, cities move ahead with boosters for all as FDA deliberates

New York City joined three states Monday in making booster shots available to all adults.
A man receives his third Covid-19 vaccine shot at Kennedy Memorial Park in Hempstead, N.Y., on Oct. 14, 2021.
A man gets his third Covid-19 vaccine shot at Kennedy Memorial Park in Hempstead, N.Y., on Oct. 14. J. Conrad Williams Jr. / Newsday via Getty Images file

All adults in New York City joined a growing group of people in the U.S. who can get Covid-19 booster shots Monday, even though federal health agencies haven’t signed off on the move.

Mayor Bill de Blasio and Dr. Dave Chokshi, the health commissioner, made the announcement, which skirts both authorization from the Food and Drug Administration and a recommendation from the Centers for Disease Control and Prevention. 

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New York City’s move to open up booster eligibility to all adults came just days after three states — California, Colorado and New Mexico — announced that they will administer boosters to any fully vaccinated adults who want them, as long as it has been six months since their second doses of either the Pfizer-BioNTech or the Moderna vaccines or two months since their first Johnson & Johnson shots. New York City will follow the same criteria

The Pfizer and the Moderna booster shots are authorized for people ages 65 and up, those living in long-term care facilities and people ages 18 to 64 who are at a higher risk because of their jobs or underlying medical conditions. The Johnson & Johnson booster is available to anyone who was initially vaccinated with the brand’s vaccine two months earlier. 

Nearly 30 million boosters had been administered in the U.S. as of Monday, according to the CDC. The majority have gone to people over 50, with just under 6 million administered to people ages 18 to 50.

The states are taking matters into their own hands less than a week after Pfizer asked the FDA for emergency use authorization for its booster shot for all adults, a move that would essentially do away with the complicated criteria surrounding eligibility. The FDA hasn’t yet decided on Pfizer's request.

But the criteria haven’t meant the boosters are out of reach for the general public

“They don’t need to provide any proof or documentation of a specific medical condition or employment. In practice, I think those individuals who want to get a booster dose regardless of their eligibility are doing so anyway, and it’s nearly impossible to enforce that,” said Dr. Martin Backer, associate director of the Vaccine Center at NYU Langone Hospital-Long Island.

Dr. Jesse Goodman, an infectious disease specialist at Georgetown University Medical Center and a former chief scientist with the FDA, said the decisions to move forward without official signoff were “unfortunate, ill-considered and a dangerous precedent for state or local governments to unilaterally extend use of the booster dose of Covid vaccines beyond current recommendations.” 

“Any such decisions should be made nationally and only after independent review by FDA and CDC,” Goodman said. “Acting based on personal opinions or politics and with incomplete data is irresponsible and undermines protections in place to help ensure the best possible decisions.”

A push for boosters for all

The pivot toward boosters for all may appear jarring; in September, during the Biden administration’s push for boosters for all adults, the FDA’s influential advisory committee denied Pfizer’s original request to recommend boosters for everyone 16 or older, citing myocarditis, a rare but serious inflammatory heart condition seen primarily in young men, among  its concerns. 

Dr. William Moss, the executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, wasn’t initially in favor. 

“When this came up in September, I was definitely in the camp that said there was insufficient data to justify booster doses in young, healthy adults,” he said. “The data presented to the FDA at that time showed vaccine effectiveness for the mRNA vaccine remained high, and that I see as our primary goal with these vaccines.” 

But since then, Moss said, more information about waning immunity, as well as the safety of the boosters, has come to light and will have to be considered.

Recent data have shown that the vaccines, especially the mRNA vaccines, remain effective against severe illness and hospitalization even now that nearly all cases are caused by the delta variant of the coronavirus — even better than health officials expected during the vaccine development phase. A study of veterans published last month in Science found that among people 65 and younger, Pfizer’s vaccine remains more than 84 percent effective at preventing death due to Covid. Moderna’s effectiveness against death was more than 81 percent, and Johnson & Johnson’s was 73 percent. 

However, studies also show that protection against infection, with or without symptoms, has weakened. A study published early last month in The Lancet found that among fully vaccinated people, Pfizer’s two-dose vaccine was 93 percent effective against infection with the delta variant one month after vaccination — but the effectiveness dropped to 53 percent after four months. 

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“The pandemic is in flux. We need to keep an open mind to new information,” said a member of the FDA advisory committee, Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, who said additional safety data that weren’t available during the September FDA meeting are now available and must be considered.

Levy and Moss recognized that the benefits of boosters must still be weighed against rare adverse events.

“An additional dose does raise a concern, because there will be some risk associated with that,” Moss said. “The most serious one people are concerned about is myocarditis, especially in younger males, which is higher with Moderna.” 

Although vaccine-induced myocarditis is rare, decision-makers aren’t taking it lightly. Although there were no cases of myocarditis in Pfizer’s and Moderna’s booster clinical trials, the trials may not have been large enough to detect such a rare side effect.  

Instead, U.S. officials have often had to look to data from Israel, where boosters have been given to all people 12 and up since late August. Data presented by Israeli scientists at an Oct. 14 FDA advisory committee meeting identified 17 cases of myocarditis or myopericarditis (another type of heart inflammation) in males ages 16 to 59 who received booster shots. The rates were lower than the number of cases seen after second doses of the vaccines. 

“No one wants to give a vaccine to someone who is healthy and have a new health problem develop as a consequence of that. We have to very carefully weigh those pros and cons when we recommend any vaccine,” Backer said.

Experts also disagree about what the aim of boosters should be: to prevent serious illness and death or to prevent serious cases and transmission. 

“It’s a very important question. I’m not sure what the uptake is going to be should Pfizer be granted an EUA for everyone older than 18,” Moss said. “Right now, about 15 percent of fully vaccinated people have got booster doses, and I think the coverage will be lower as you go into lower age groups. I don’t think this is going to be a game changer in terms of the pandemic control in the U.S.” 

Backer said boosters can offer only so much protection if some people are still unvaccinated. 

“What would have the most impact would be if the unvaccinated people would get vaccinated,” he said. “It’s not that I disagree with boosters, but the difference between no vaccine and one vaccine is much bigger than the difference between a full dose and a full dose with a booster.”

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