COVID-19 vaccine, FDA
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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 notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to update their vaccines.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults.
After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.
FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.