FDA, COVID-19
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New COVID-19 variant NB.1.8.1 is causing concern in California, where it was first detected by Stanford scientists. The FDA, under Robert F. Kennedy Jr., has controversially limited vaccine eligibility,
The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.
Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which vaccines to authorize or approve after being deemed safe and effective.
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.
The FDA 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.
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines,
A new Covid variant that’s gaining momentum globally has landed in the U.S. The World Health Organization announced last week that it was monitoring the variant, NB.1.8.1, following a rise in cases in several parts of the world, including Europe, Southeast Asia and North and South America.