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Johnson & Johnson seeks emergency authorization for coronavirus booster

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WASHINGTON - Johnson & Johnson asked the Food and Drug Administration on Tuesday to grant emergency use authorization for a booster dose of its single-shot coronavirus vaccine, making it the final vaccine used in the United States for which permission is being sought for an extra shot.

The action is part of an effort by Biden administration officials to provide increased protection against covid-19, the disease caused by the coronavirus, which has claimed more than 700,000 lives in the United States.

The filing came as a top FDA official said updated data might make a strong case that everyone 18 and older should be eligible for boosters - but added that the agency will have to see whether its outside advisory committee agrees. The FDA plans to meet Oct. 14 and 15 with its vaccine advisory committee to discuss boosters for the Moderna and Johnson & Johnson vaccines, respectively.

Peter Marks, director of the Center for Biologics Evaluation and Research, also said on a webinar the FDA hoped to have "a harmonized approach" to boosters for all three coronavirus vaccines being used in the United States - and to make the eligibility standards simpler for people to understand.

In its submission to the FDA, Johnson & Johnson is asking the agency "to look at our data and agree with us that we have enough data to support a boost" for people 18 and older, said Mathai Mammen, global head of research and development for the Janssen Pharmaceuticals division of Johnson & Johnson.

Based on the data, Mammen said in an interview, the company believes the best immune response occurs when a booster is administered at least six months after vaccination. But he said the company was not formally recommending one interval over another. Instead, the FDA and its outside advisers will determine the appropriate interval between the initial vaccination and the booster, he said.

The company, in a statement issued Tuesday, said the data packet for the FDA includes recent results from a Phase 3 trial in the United States that found an extra shot given about two months after the primary dose provided 94% protection against moderate to severe covid-19, up from 73% for the first shot. Protection was 100% two weeks after the booster was administered. The booster provided a three- to fourfold increase in antibodies, according to the data.

Johnson & Johnson said it also submitted data to the FDA showing that when the booster was administered at least six months after the initial shot, antibody levels increased ninefold one week after the extra shot and 12-fold four weeks after the booster.

The advisers will also review data from the National Institutes of Health about "mixing and matching" boosters - using different brands from the initial shots. Officials have made clear they think boosters are needed to counter waning immunity caused by the delta variant of the virus, or by the passage of time, or by some combination.

The FDA has authorized a booster for people who received the Pfizer-BioNTech two-shot regimen. The extra dose is cleared for use at least six months after the second shot for people 65 and older and for those with underlying medical conditions or occupational exposure that raises their risk of severe covid-19. Biden administration officials had indicated in mid-August that they favored a broader approach, making anyone 18 and older eligible for boosters. But the FDA's advisory committee balked.

If the advisers do not endorse a broad authorization for people 18 and older in next week's meetings, the FDA's fallback position might be to authorize boosters for people 40 and up, and for younger people with medical conditions, jobs or living situations that make them more vulnerable to covid-19, according to people familiar with the FDA's thinking who spoke on the condition of anonymity because they did not have authorization to discuss internal plans.

Since the Johnson & Johnson shot was cleared by the FDA in February, 14.8 million people in the United States have received the vaccine, according to the Centers for Disease Control and Prevention. About 102 million people have gotten the two-dose regimen for Pfizer-BioNTech, and 69 million for Moderna, according to the CDC.

Published : October 06, 2021

By : The Washington Post