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An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...
The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...
The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
New guidelines for COVID vaccine. Prior to the new guidelines, it was recommended that everyone who is 6 months and older get ...
For groups younger than 65 or without specific chronic conditions, postmarketing trials will be needed to open access.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
New requirements for clinical testing of vaccines, announced this month, may delay the availability of shots that had ...
“The 2024–2025 COVID vaccine, which was released last fall, is still recommended for everyone aged six months or over,” the ...
The shift was a marked departure from previous FDA guidance, which recommended an annual COVID vaccine for everyone 6 months ...