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.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
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.
Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter
The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.
The Food and Drug Administration is adjusting the standard of evidence needed for shots to be approved by the general public.
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.