FDA, COVID 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.
New guidelines for COVID vaccine. Prior to the new guidelines, it was recommended that everyone who is 6 months and older get at least one vaccine per year, with those in higher-0
New requirements for clinical testing of vaccines, announced this month, may delay the availability of shots that had formerly been updated annually without complicated trials.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to green-lighting shots that have been recommended broadly to the public.