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The Food and Drug Administration is shifting its annual COVID-19 vaccine approval policies to focus on Americans older than age 65 and other "high-risk" individuals, while increasing the standard of evidence to approve COVID vaccines for low-risk individuals.
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," FDA's Center for Biologics Evaluation and Research chief, Vinay Prasad, and FDA Commissioner Martin Makary, wrote in the New England Journal of Medicine...
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