Novavax’s COVID vaccine gets FDA approval
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In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it says.
"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.
Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy.
The FDA finally approved Novavax's Covid-19 vaccine, but placed restrictions on it that its two competitors in the U.S. do not face