COVID, vaccine guidelines
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For groups younger than 65 or without specific chronic conditions, postmarketing trials will be needed to open access.
The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with
The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
"Here is a prime example of just how influential Big Pharma still is," MAHA influencer Diana Atieh told Newsweek.
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.