FDA plans to limit COVID vaccine to only high-risk people
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The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.
The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”
The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials.
Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many others may not be able to get the shots.
Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for approving future Covid-19 vaccines that he feels will counteract existing “dogma.”
Wellbeing Whisper on MSN1d
Why Most Americans Won't Need Covid Boosters Anymore and What It Means for YouWe want to know more about what these products are doing,” said Dr. Vinay Prasad during a recent FDA livestreamed presentation. This statement comes amidst a significant shift in the U.S. Food and Drug Administration’s (FDA) policy on Covid-19 booster shots.
1don MSN
Long before he joined the FDA to run the center that regulates vaccines, Vinay Prasad argued against COVID shots for kids. Among his many criticisms of the United States’ approach to combatting the disease,