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WASHINGTON — Johnson & Johnson issued a statement from federal regulators earlier this week. additional insignia According to officials familiar with the company’s plans, the coronavirus vaccine. The firm is at least the last of three federally authorized vaccine providers to request additional injections, amid growing evidence that the elderly and other high-risk groups need more protection.

Federal officials are increasingly concerned that the more than 15 million Americans who receive the Johnson & Johnson vaccine face too many serious risks of Covid-19. The Food and Drug Administration scheduled a meeting for Friday, Oct. 15, of the expert advisory committee to discuss whether emergency use authorization should be granted. amplifier Shot of Johnson & Johnson’s vaccine.

This is part of the government’s broader effort to support the protection provided by all three vaccines. last month editors allowed a booster shot for many buyers Pfizer-BioNTech‘s vaccine, and they plan to do the same for Moderna’s buyers this month.

The fact that the advisory board meeting on Johnson & Johnson was scheduled before the company filed with the Food and Drug Administration reflects a special sense of urgency from the Biden administration to provide further protection to recipients of this vaccine.

Although the federal government has emphasized for months that all three vaccines are highly effective, a new study The Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was only 71 percent effective against hospitalizations from Covid-19, compared to 88 percent for Pfizer-BioNTech’s vaccine and 93 percent for Moderna’s vaccine.

“Real world data, two doses of Moderna and Pfizer-BioNTech The mRNA vaccine regimens offered greater protection than a single dose of Johnson & Johnson, the researchers said. Other research has found that Johnson & Johnson recipients are more likely to have breakthrough infections or symptomatic Covid-19 than those who receive the other two vaccines.

Johnson & Johnson cites some of the better research: A company-funded study of nearly two million people estimated that the vaccine was 81 percent effective against hospitalization. Other research shows that protection from Johnson & Johnson’s vaccine does not decrease over time like protection from Pfizer-BioNTech’s vaccine.

However, Johnson & Johnson now appears to agree with federal officials that a single shot of the vaccine is not enough.

Last month, the company announced a second doseincreased the effectiveness of the vaccine against symptomatic Covid-19, given two months after the first, by about 22 points, to 94 percent. The firm also said that two shots were 100 percent effective against severe disease, although this estimate is less precise.

“The data show a dramatic increase in efficacy when the boost is given at two months. We believe it is potentially better when given later,” said Dr. Dan H. Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who helped develop the vaccine.

“I am not a public health official, but I would say it is scientifically reasonable for people who want a higher level of efficacy to achieve a higher level of efficacy. additional insignia“Two to six months after the first shot of the vaccine,” he said.

At a CDC advisory committee meeting in September, some independent experts questioned whether Johnson & Johnson buyers had been forgotten as the federal government moved to authorize a third shot for Pfizer buyers.

A specialist in internal medicine and infectious diseases at Vanderbilt University, Dr. “In my opinion, the biggest policy question on the market is Johnson & Johnson,” Helen Keipp Talbot said at the committee’s meeting last month when she was considering whether to recommend a third vaccine. for some Pfizer buyers. “I’m worried about being distracted by the question of Pfizer’s boosters while we have bigger and more important things to do during the pandemic.”

Maine’s top health official and president of the Association of State and Regional Health Officials, Dr. Nirav D. Shah said after the Johnson & Johnson vaccine became available this spring, many states are diverting it to rural areas. because it only required one injection and easier to carry.

Dr. “Rural areas are currently particularly hit by the Delta variant,” Shah said. “So I think there’s good reason to offer a boost to J. & J. buyers if the data supports it.”

Last month in San Francisco, health officials said Johnson & Johnson recipients would be allowed to get a booster shot for the Moderna or Pfizer vaccine. The townspeople Dr. “If people talk to their healthcare providers and say, ‘I’d really like to have an mRNA vaccine in addition to the Johnson & Johnson vaccine that I had,’ we’re going to adapt,” said Grant Colfax. The health director told reporters.

Key questions remain for federal regulators and government panels of outside experts: How soon after the first Johnson & Johnson injection should a second shot be fired? And would it be better to supplement Johnson & Johnson buyers with a shot of Moderna’s or Pfizer’s vaccine?

If the Food and Drug Administration allows a second shot six months after the first injection, that would allow the company to market its vaccine as a one-shot regimen plus a booster. Some data show that a second shot at six months produces a stronger immune response than a second shot at two months.

Researchers found Dr. There was a nine- to twelve-fold increase in antibodies among clinical trial recipients who received a second vaccine six months later, and a roughly four-fold increase in those who received a second dose two months later, Barouch said.

But there may be a trade-off: Some argue that Johnson & Johnson recipients won’t be adequately protected for the extra months before a second shot, and that a two-dose regimen makes more sense from the start.

Timing is no trivial question: More than two-thirds of Johnson & Johnson recipients were vaccinated at least four months ago, according to CDC data. If a booster shot could be given just six months after the first injection, many would not be immediately available.

The possibility of using a different vaccine as a booster presents another dilemma. A study by the National Institutes of Health shows that Moderna’s vaccine works better as a booster than a second shot from Johnson & Johnson. However, Dr. Barouch said that while Johnson & Johnson’s study of a second shot of its own vaccine looked at efficacy data, the study only measured antibody levels — an indication of the strength of the immune system’s response.

It’s also likely that Johnson & Johnson will fight to use its own vaccine as a second shot to maintain its public image. The company struggled for months. production problems this delayed the delivery of tens of millions of doses promised to the federal government. And the vaccine’s appeal fell after it was associated with a virus. rare but serious blood clotting disorder and injections were stopped for 10 days in April. It remains a distant third in the number of shots administered in the United States.

Individuals who qualify for Pfizer’s support include those aged 65 and over, and a group that includes healthcare professionals who live in long-term care facilities, have underlying medical conditions, or are at higher risk of exposure because of their work or corporate environment. , teachers and inmates.

The Food and Drug Administration and CDC are expected to recommend essentially the same criteria for booster shots of Moderna and Johnson & Johnson, but there is some debate over whether to expand eligibility to include more middle-aged people, according to people familiar with the matter. situation.

Moderna’s booster authorization request Next is a meeting scheduled for October 14, the day before the Johnson & Johnson debate. Some experts suggest that the company’s supporting data is even more scant than Pfizer’s.

Multiple studies show the potency of Moderna’s vaccine decreases less over time More from Pfizer. Moderna officials suggest this is because the dosage is stronger and the interval between shots is a week longer than with the Pfizer regimen.

On the other hand, setting a precedent for the government to authorize a Pfizer booster could create momentum for extra shots of the other two vaccines. Otherwise, paramedics are left with trying to explain why only Pfizer buyers are eligible for promoters.

For example, in Maine, Dr. Shah said the medical staff who gave the booster injections told nursing home residents: “We’re really sorry, for those who only have Pfizer right now, but don’t worry. Just because you can’t get a booster today doesn’t mean your protection level has dropped to zero. We’ll be back when the boosters for other vaccines are cleared.”

“This is a difficult conversation to have,” he said.

More support may come from Israeli health officials, who presented data on a Pfizer booster at the Food and Drug Administration’s advisory board meeting last month. Israel relies almost entirely on Pfizer’s vaccine.

Extra shots of Pfizer’s vaccine are associated with significantly lower infection rates, severe Covid-19, and death among those aged 60 and over, according to summaries of the country’s latest data.

At this point, federal officials and some outside experts of the government admitted that they were making decisions with imperfect data. As with other vaccines, data on the efficacy of Johnson & Johnson are fragmented and to some extent contradictory, these differences may be at least partially explained by whether the highly contagious Delta variant predominates in the population studied.

Dr. “The data is a bit ubiquitous,” Shah said. “That is the nature of science.”

Noah Weiland contributing reporting.