FDA, COVID-19 testing
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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 agency recommends manufacturers update their vaccines to target the JN.1 strain. At the same time, HHS head Robert F. Kennedy Jr. is removing guidance that healthy children and pregnant women receive COVID shots.
The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.
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.
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.