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Moderna did not meet all criteria for COVID boosters: FDA staff

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eMediNexus    13 October 2021

Scientists at the U.S. Food and Drug Administration have stated that Moderna Inc did not meet all the criteria to back the use of booster shots of its COVID-19 vaccine, likely because the efficacy of the vaccine’s first two doses continued to be strong.

FDA staff stated that data for the Moderna COVID-19 vaccine indicated that a booster shot increased protective antibodies; however, the difference in the level of antibodies before and after the shot was not too wide, especially in individuals whose levels had continued to be high.

While the FDA usually follows the advice of its experts, the agency is not bound to do so. A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will convene next week to talk about the specific recommendations on who can receive the booster shots, if authorized by the FDA… (Reuters, October 13, 2021)

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