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FDA plans to authorize new omicron-targeted COVID-19 boosters for people 12 and older as early as Labor Day

The new boosters target the BA.5 omicron subvariant. Shots could begin shortly after the Labor Day weekend.
/ Source: NBC News

The Food and Drug Administration is planning to authorize updated versions of Pfizer-BioNTech and Moderna’s COVID-19 boosters around Labor Day, according to two people familiar with the discussions.

The Biden administration is preparing to distribute the updated booster shots to teens and adults as part of its fall booster campaign.

Both Pfizer and Moderna’s reformulated shots target the BA.4 and BA.5 omicron subvariants in addition to the original coronavirus strain in a single shot. BA.5 is responsible for nearly 90% of all new COVID-19 cases in the United States, according to data from the Centers for Disease Control and Prevention

Pfizer is seeking authorization for people 12 and older, while Moderna is seeking authorization for all adults.

The FDA does not plan to convene its advisory panel, called Vaccines and Related Biological Products Advisory Committee, ahead of the authorization, one person said.

The FDA’s authorization will not be the final step before the shots can be distributed. The Centers for Disease Control and Prevention must also sign off; the agency plans to convene its advisory panel, called the Advisory Committee on Immunization Practices, on Thursday, Sept. 1, and Friday, Sept. 2 to discuss COVID-19 boosters, according to the agency.

CDC Director Dr. Rochelle Walensky could sign off on the updated boosters shortly after the two-day meeting. Vaccinations with the updated shots could begin as early as the day after the national holiday, one the people said.

The plan still could change, the people said.

The federal government is hoping that by modifying the vaccines to better match circulating strains, it will improve the shots’ effectiveness and perhaps provide longer-lasting immunity.

Both Pfizer and Moderna’s applications included data on how well the BA.4/BA.5 booster shot performed in animal studies, but studies in humans have yet to be completed.

The decision to move forward without complete data from human trials has been a sticking point for some outside scientists who say the new shots haven’t demonstrated that they are any better than the existing vaccines from Pfizer and Moderna.

Other scientists have praised the unprecedented speed at which Pfizer and Moderna developed the new boosters. BA.5 only began spreading throughout the U.S. in early June.

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