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US Regulators Prepared To Clear COVID-19 Vaccine For Young Children Despite Substandard Efficacy: Lawmaker

us-regulators-prepared-to-clear-covid-19-vaccine-for-young-children-despite-substandard-efficacy:-lawmaker

The U.S. Food and Drug Administration (FDA) will not enforce an effectiveness standard when considering whether to authorize one or more COVID-19 vaccines for young children, a top member of Congress said.
Dr. Peter Marks, head of the Center for Biologics Evaluation and Research, said during a recent briefing that the FDA “would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection—a requirement that had been previously listed in FDA guidance,” Rep. Jim Clyburn (D-S.C.), chairman of the House Select Subcommittee on the Coronavirus Crisis, said in a summary of the briefing released on May 9.
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