FDA panel says Covid vaccines can stay the same for fall amid access concerns

A sense of unease permeated the Food and Drug Administration’s vaccine advisory committee meeting Thursday.
A sense of unease permeated the Food and Drug Administration’s vaccine advisory committee meeting Thursday.
The advisers had convened for what’s become a standard practice over the past few years: selecting a new strain for the fall’s updated Covid vaccines.
Complicating matters, however, were new FDA rules for the updated Covid vaccines, announced just days earlier, that would restrict access of the shots to only the most at-risk Americans.
Under the rules, updated Covid vaccines for healthy children and adults under 65 must undergo additional placebo-controlled clinical trials — meaning some people would get the actual vaccine while others would get an inactive substance like a saline shot.
The original Covid vaccines, approved in late 2020, went through this process. Since then, drugmakers transitioned over to a flu-vaccine model, using smaller studies to test whether the shots generated an immune response against the variant in question.
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