FDA, COVID-19 and Vaccine
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The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
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,
Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy
Secretary Kennedy's appointment led to fears that vaccine availability would be curtailed. Those fears are now being realized.
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.
Large, lengthy studies will be needed for the agency to approve boosters for healthy adults and children, regulators said.
Top officials with the U.S. Food and Drug Administration are changing the agency's standards for updated COVID-19 booster shots, potentially limiting approval for the vaccines to seniors and others at high risk of complications from the disease.