FDA, COVID-19 and vaccine
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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.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.
FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad said based on data from tests that measure immune response in patients, they anticipate that the FDA will be able to approve the boosters for adults over the age of 65 years.
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