Johnson & Johnson will seek FDA authorization for booster shot

WASHINGTON — Johnson & Johnson plans to ask federal regulators earlier this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. Amid mounting evidence that at least the elderly and other high-risk groups need more protection, the firm is the last of three federally authorized vaccine providers to call for additional injections.

Federal officials have become increasingly concerned that the more than 15 million Americans who have received the Johnson & Johnson vaccine are at very high risk of severe COVID-19. The Food and Drug Administration on Friday scheduled a meeting of its expert advisory committee for October 15 to discuss whether to approve emergency use authorization for Johnson & Johnson’s vaccine booster shot.

This is part of a wider effort by the government to enhance the protection provided by all three vaccines. regulator last month authorized a booster shot Pfizer is looking to do the same for multiple recipients of BioNTech’s vaccine and this month for recipients of Moderna.

The fact that the advisory committee meeting on Johnson & Johnson was scheduled even before the company filed an application to the Food and Drug Administration to provide more protection to recipients of that vaccine created a particular sense of urgency in the Biden administration. It reflects.

Although the federal government has insisted for months that all three vaccines are highly effective, recent study 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, found by the Centers for Disease Control and Prevention. .

“Real-world data suggests that the two-dose Moderna and Pfizer-BioNTech mRNA vaccine regimens provide greater protection than the single-dose Johnson & Johnson regimens,” the researchers said. Other research found that Johnson & Johnson recipients were more likely to have a breakthrough infection or symptomatic COVID-19 than recipients of the other two vaccines.

Johnson & Johnson cites a few studies with better results: A study of nearly two million people funded by the company estimated that the vaccine was 81 percent effective against hospitalization. Other research suggests that protection from the Johnson & Johnson vaccine does not decrease over time like the protection from the Pfizer-BioNtech vaccine.

Nonetheless, Johnson & Johnson now agrees with federal officials that one shot of its vaccine is not enough.

last month, The company announced that a second dose, two months after the first, increased the vaccine’s effectiveness against symptomatic COVID-19 by about 22 percentage points to 94 percent. The firm also said that the two shots were 100 percent effective against severe disease, although that estimate was less conclusive.

“The data shows there is a dramatic increase in efficacy when given a boost over two months. And we believe it is potentially even better when given later,” said Beth Israel Deaconess Medical Center in Boston Dr. Dan H. Baruch, a virologist in the U.S. who helped develop the vaccine.

“I am not a public health authority, but I would say that it is scientifically reasonable for people who wish to have a high level of efficacy to receive a booster shot” between two and six months after the first shot of the vaccine. , They said.

At a meeting of the CDC advisory committee in September, some independent experts questioned whether Johnson & Johnson recipients were being forgotten while the federal government moved to authorize a third shot for Pfizer recipients.

“To me, the biggest policy question is Johnson & Johnson,” Dr. Helen Kiep Talbot, an internist and infectious disease specialist at Vanderbilt University, told the meeting last month. For some Pfizer recipients. “I worry that we are getting distracted by the question of Pfizer’s boosters when we have bigger and more important things to do in the pandemic.”

Dr. Nirav D. Shah, Maine’s top health official and president of the Association of State and Territorial Health Officials, said after the Johnson & Johnson vaccine became available this spring, many states directed it to rural areas. Because it requires only one injection And it was easy to transport.

“It is rural areas that are being particularly affected right now” by Delta Edition, Dr. Shah said. “So I think there’s a good reason to offer the booster to J&J recipients if the data backs it up.”

In San Francisco last month, health officials said Johnson & Johnson recipients would be allowed to receive a booster shot of the Moderna or Pfizer vaccine. “If people talk to their health care provider and say, ‘I really want to have an mRNA shot in addition to the Johnson & Johnson shot,’ we’ll adjust that,” said Dr. Grant Colfax, the city’s director of public health, told reporters.

For federal regulators and the government’s panel of outside experts, key questions remain: How long after an initial Johnson & Johnson injection should a second shot be administered? And would it be better to boost Johnson & Johnson recipients with a shot of the vaccine from Moderna or Pfizer?

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

researchers found There was a nine- to twelve-fold increase in antibodies in clinical trial recipients who received the second shot after six months, compared with an almost four-fold increase for those who received the second dose after two months, Dr. Baruch said.

But there may be a trade-off: Some argue that Johnson & Johnson recipients would not be adequately protected during the additional months before the second shot, and that the two-dose regimen made more sense from the start. Came.

Timing is no trivial question: According to CDC data, more than two-thirds of Johnson & Johnson recipients were vaccinated at least four months ago. Many will not be eligible immediately if a booster shot is available only six months after the first injection.

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

Johnson & Johnson is also considered likely to fight for using its own vaccine as a second shot at protecting its public image. The company struggled for months construction problem Which delayed the delivery of millions of doses that the federal government had promised. And the appeal of the vaccine fell after being linked to a rare but serious blood clotting disorder And injection was stopped For 10 days in April. It ranks third in the number of shots administered in the United States.

People eligible for Pfizer’s boosters include people age 65 and older and those who live in long-term care facilities, have underlying medical conditions, or are at high risk of exposure to the virus because of their jobs or institutional settings. is a group that includes health care workers, teachers and prisoners.

The Food and Drug Administration and the CDC are expected to propose essentially similar criteria for booster shots from Moderna and Johnson & Johnson, although there is some discussion about whether eligibility should be changed to include more middle-aged people. To be broadened, that is, according to the people familiar. Situation.

Moderna’s request for authorization of a booster The shot is next, with a meeting scheduled for October 14, a day before the Johnson & Johnson discussion. Some experts suggest that the company’s support data is even lower than that of Pfizer.

Several studies indicate that the potency of Moderna’s vaccine diminishes over time Compared to Pfizer. Moderna officials suggest that this is because the dosage is stronger and the interval between shots is one week longer than on Pfizer’s regimen.

On the other hand, the fact that the government has set a precedent in authorizing the Pfizer booster could generate momentum for additional shots of the other two vaccines. Otherwise, health care officials are trying to explain why only Pfizer recipients are eligible for a booster.

In Maine, for example, Dr. Shah said health care workers who are giving booster injections are telling nursing home residents: “We’re really sorry, right now it’s only for people who got Pfizer. But don’t worry. Just because you can’t get a booster today doesn’t mean your level of protection is zero. We’ll come back if and when the boosters for other vaccines have cleared.

“It’s a difficult conversation,” he said.

More support could come from Israeli health officials, who presented data on the Pfizer booster at a Food and Drug Administration advisory committee hearing last month. Israel is almost entirely dependent on Pfizer vaccines.

In addition to Pfizer’s vaccine, shots are associated with significantly lower rates of infection, severe COVID-19, and death in people 60 or older, according to a summary of the country’s latest data.

At this point, federal officials and some outside government experts acknowledge that they are making decisions with data that is less than perfect. As with other vaccines, data on the efficacy of Johnson & Johnson are fragmentary and somewhat contradictory, with discrepancies that may be at least partly explainable as to whether the highly infectious delta variant was dominant among the populations being studied.

“The data is everywhere to some extent,” Dr. Shah said. “That’s the nature of science.”

Noah Weiland Contributed reporting.

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