FDA Approves New COVID Vaccine
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The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary, said in an editorial published Tuesday in the New England Journal of Medicine
The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.
The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 and up, along with people ages 12 and up who have at least one underlying condition that puts them at risk of severe disease.
WASHINGTON (AP) — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.
Data shows that the two-dose measles vaccine is 97% effective at preventing measles and experts say protection doesn’t wane.
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