FDA, COVID
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The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans — a move that will limit future vaccines to older Americans and people at higher risk of serious Covid-19 infection.
"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.
9hon MSN
The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.
The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with
The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to green-lighting shots that have been recommended broadly to the public.
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