Novavax scores narrower Covid vaccine approval
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"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," the agency said in an article published by The New England Journal of Medicine, authored by FDA Commissioner Dr. Martin Makary and his new top vaccines official, Dr. Vinay Prasad.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.