FDA, Covid
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Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. | FDA Commissioner Marty Makary, M.D., and CBER head Vinay Prasad, M.D.
FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers for annually updating their Covid-19 shots.
US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly requirement for drugmakers, though they will still be available for millions of high-risk Americans.
Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults.