Nuvaxovid FDA Approval Unlocks Several Bullish Stimuli
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The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
"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 U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability this fall to older adults and those with a higher risk of developing severe illness,
In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well as children and younger adults who have one or more risk factors that make them more vulnerable to severe COVID-19.