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J&J asks FDA to authorize COVID-19 vaccine booster shot

By Jonna Lorenz
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J&J asks FDA to authorize COVID-19 vaccine booster shot
A member of the clergy receives a Johnson & Johnson COVID-19 vaccine at the National Cathedral in Washington, D.C., on March 16. File Photo by Kevin Dietsch/UPI | License Photo

Oct. 5 (UPI) -- Johnson & Johnson on Tuesday asked the U.S. Food and Drug Administration to authorize a booster shot of its COVID-19 vaccine for adults age 18 and older.

"Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94%," Dr. Mathai Mammen, global head of J&J's Janssen Research & Development division, said in a statement.

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The company is not recommending a specific interval of time between the first dose and the booster.

"We're providing them data and we're going to be presenting to the committee," Mammen told CNN. "They'll take all of that into consideration when they ultimately decide on an appropriate interval."

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In September, Johnson & Johnson released data from studies showing an increased immune response in volunteers who received second doses of its Janssen COVID-19 vaccine two to six months after their first dose.

Those studies showed that antibody levels rose highest -- between nine and 12 times -- when the booster shot was given at least six months after the first dose. They also showed that boosters given two months after the initial dose provided 94% protection against symptomatic COVID-19 in the United States.

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On Friday, the FDA announced three coming meetings to address vaccine booster shots and vaccines for children younger than 12.

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The agency will meet on Oct. 14 and 15 about Janssen and Moderna COVID-19 vaccine boosters and Oct. 26 to consider Pfizer's request for emergency use authorization for its COVID-19 vaccine in children ages 5-11.

The FDA also will consider data from the National Institutes of Health concerning whether to administer booster shots of a different brand than the initial vaccine.

The FDA approved boosters of the Pfizer/BioNTech COVID-19 vaccine on Sept. 22 for people 65 and older, those at high risk for severe disease and those who are at frequent risk of exposure. Nearly 2 million booster shots were administered in the first week of eligibility.

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On Monday, the European Union drug regulator recommended Moderna and Pfizer COVID-19 booster shots for immunocompromised individuals.

More than 14.8 million people in the United States have received the Johnson & Johnson vaccine since the FDA granted emergency use authorization in February, the Washington Post reported. The vaccine has been linked to rare side effects, including blood clots and Guillain-Barre syndrome, and was temporarily halted in April.

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