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You are here News Health U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters

U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters

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Moderna does not yet meet FDA criteriaScientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc (MRNA.O) had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.

FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.

The documents were released ahead of a meeting later this week of the FDA's outside expert advisers to discuss booster doses of the vaccine.

The FDA typically follows the advice of its experts, but is not bound to do so. A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to discuss specific recommendations on who can receive the boosters, if the FDA authorizes them.

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