COVID-19 vaccine, FDA
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Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults.
The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to update their vaccines.
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.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy.
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.
(Reuters) -Moderna said on Friday it had filed a marketing application for an updated COVID vaccine to the U.S. Food and Drug Administration.