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The F.D.A. recommends Covid boosters be retooled to incorporate the Omicron subvariants BA.4 and BA.5.

WASHINGTON — The Food and Drug Administration said on Thursday that it advised coronavirus vaccine manufacturers to update their booster formulations to target the rapidly spreading Omicron subvariants known as BA.4 and BA.5, which are now estimated to be responsible for more than half of virus cases in the United States. United States.

The decision came just two days after the agency’s committee of independent vaccine experts overwhelmingly voted for regulators to use more advanced vaccines that would contain forms of Omicron, a recognition that by then current injections may no longer be sufficiently protective for at least some Americans a possible fall or winter wave is coming.

“As we enter the fall and winter, it is critical that we have safe and effective vaccine boosters that can protect against circulating and emerging variants,” said Dr. Peter Marks, who oversees the FDA’s vaccine agency, said in a statement Thursday.

dr. Marks said the agency did not ask manufacturers to change the formulation for the initial doses of their coronavirus vaccines, as the current formulation “provides a basis for protection against serious consequences.”

“We expect this next year to be a transition period where this modified booster vaccine can be introduced,” he said.

The choice to target the sub-variants, arguably the most transmissible coronavirus variants to date, was clouded by significant uncertainty about what form the virus might take later this year, leaving the design of Covid-19 footage uncomfortably guesswork for Pfizer-BioNTech and Moderna, the two major manufacturers, and the federal scientists charged with guiding them in tailoring their products.

Pfizer and Moderna are expected to follow the FDA’s recommendation and begin producing reformulated doses this summer, with a view to having them ready by the fall if federal regulators clear them for another booster campaign. Pfizer said Tuesday that a shot targeting its chosen sub-variants could be ready for use in early October, while Moderna expects availability in late October or early November.

Sharon LaFraniere reporting contributed.

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