COVID, FDA
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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 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 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.
Data shows around 300 deaths a week in mid-April as the FDA rolls out more-stringent vaccine approval rules.
The United States, traditionally the top donor to the UN health agency, was not part of the final stages of pandemic agreement process after the Trump administration announced a pullout from the WHO.
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HHS Secretary Robert F. Kennedy Jr. outlines reasons for U.S. withdrawal from WHO, highlighting failures in COVID-19 response and China's influence on the organization.