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U.S.plans to offer revised COVID Booster shots in early September

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WASHINGTON — The Biden administration plans to offer the next generation of coronavirus booster shots to Americans 12 and older soon after Labor Day, a campaign that federal officials hope will reduce deaths from Covid-19 and protect against an expected winter surge.

Dr. Peter Marks, the top vaccine regulator for the Food and Drug Administration, said in an interview on Tuesday that his team was close to authorizing updated doses that would target the versions of the virus now circulating.

Even though those formulations have not been tested in humans, he said, the agency has “extremely good” data showing that the shots are safe and will be effective. “How confident am I?” he said. “I’m extremely confident.”

This week, both Moderna and Pfizer-BioNTech finalized their submissions to the F.D.A. asking for emergency authorization of booster shots aimed at BA.5 and another subvariant of Omicron that together account for most coronavirus cases in the United States.

Federal health officials say they are eager to offer the updated boosters as quickly as possible, pointing to a death toll that now averages about 450 Americans per day and could rise in the coming months as people spend more time indoors.

“We have really got to do better to protect the American public,” Dr. Anthony S. Fauci, President Biden’s chief medical adviser, said in an interview on Tuesday. “We are in the middle of a BA.5 outbreak here, and we are nowhere near where we want to be.”

The Biden administration has struggled to convince Americans of the need for successive vaccinations. Only about two-thirds of the population has been inoculated with the primary series of two shots, and far fewer have received booster doses.

Some outside scientists have said the government is moving too fast to clear redesigned shots, arguing that the existing vaccines provide strong protection against severe disease. ...

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