Coronavirus: Johnson & Johnson asks FDA to authorize COVID-19 vaccine booster

WASHINGTON — Johnson & Johnson has asked the U.S. Food and Drug Administration to authorize a booster dose for the company’s one-shot coronavirus vaccine, multiple news outlets are reporting.

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According to The Associated Press, the company filed the request with regulators on Tuesday. Although the drugmaker did not formally recommend when booster shots should be given, it shared data about the efficacy of doses given at various intervals, the news agency reported.

More than 15 million doses of J&J’s vaccine have been administered in the United States, the Centers for Disease Control and Prevention reported.

The news came more than a week after Rochelle Walensky, director of the CDC, signed off on allowing booster shots for the Pfizer-BioNTech COVID-19 vaccine for people ages 65 and older, residents of long-term care facilities and vulnerable Americans ages 18 to 64, according to the AP. Her recommendation also included boosters for people who work in health care or other fields with increased risks, as well as those who live in prisons, homeless shelters and other group settings.

The FDA said last week that its expert advisory committee plans to meet Oct. 14 to discuss possible emergency use authorization of a booster shot of Moderna’s COVID-19 vaccine. The committee will discuss the possibility of a J&J booster the next day, according to the FDA’s website.

In a news release last month, J&J said a Phase 3 study found that a second dose given 56 days after the first shot provided 94% protection against symptomatic COVID-19 in the U.S., 75% protection against symptomatic illness globally and 100% protection against severe or critical illness.

Antibody levels following a second dose administered two months after the first “rose to four to six times higher than observed after the single shot,” the company said in the Sept. 21 release. Meanwhile, a booster administered six months after the first shot prompted a nine-fold increase in antibody levels one week after the second dose, and a 12-fold increase four weeks after the second shot, the release said.

In another study, researchers also found that a single dose of the vaccine “showed strong and long-lasting protection in the real world,” according to the release. Citing data collected from March to late July in the U.S., the company said the single-shot vaccine demonstrated 79% efficacy at preventing COVID-19-related infections and 81% efficacy at preventing hospitalizations.

“There was no evidence of reduced effectiveness over the study duration, including when the delta variant became dominant in the U.S. Sequencing data were not available for analysis,” the release said of the study, which included 390,000 vaccinated people and 1.52 million unvaccinated people.

The company’s studies have not yet been peer-reviewed, the AP reported at the time.

According to a recent CDC study, Johnson & Johnson’s single-dose vaccine demonstrated 71% efficacy at preventing hospitalizations, The New York Times reported.

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The Associated Press contributed to this report.

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