Johnson & Johnson seeks emergency authorization for coronavirus booster

WASHINGTON - Johnson & Johnson on Tuesday asked the Food and Drug Administration to grant emergency use authorization for a booster dose of its single-shot coronavirus vaccine.

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.

Johnson & Johnson "is asking the FDA 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 that found an extra shot given about two months after the primary dose provided 94 percent protection against moderate to severe covid-19, up from 73 percent in the United States. Protection was 100 percent 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 FDA plans to meet Oct. 14 and 15 with its vaccine advisory committee to discuss boosters for the Moderna vaccine and for the Johnson & Johnson vaccine, respectively.

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 already 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.

Moderna has also filed a request to the FDA to grant emergency use authorization for a booster following its two-dose regimen.

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.

Federal officials have warned that the Johnson & Johnson vaccine is linked to rare side effects including blood clots and Guillain-Barre syndrome, a neurological problem, but have said the vaccine’s benefits in preventing covid-19 far outweighed any risk.