FDA, COVID
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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.”
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 FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of serious illness
The US Food and Drug Administration (FDA) announced today that it will only recommend COVID-19 vaccines for adults 65 and older and people at risk for severe illness. In a marked departure from the current recommendations of seasonal vaccination for anyone 6 months and older,
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," the agency said in an article published by The New England Journal of Medicine, authored by FDA Commissioner Dr. Martin Makary and his new top vaccines official, Dr. Vinay Prasad.
In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well as children and younger adults who have one or more risk factors that make them more vulnerable to severe COVID-19.
In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin Makary, FDA commissioner, explained their plan for how the FDA will evaluate and recommend COVID-19 vaccines going forward.
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.
FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.
A change in recommending Covid vaccines for children and pregnant women would circumvent an expert panel but please many MAHA fans.