FDA panel says Covid vaccines can stay the same for fall amid access concerns [View all]
Source: NBC News
May 22, 2025, 4:35 PM EDT
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.
New Covid vaccines for another group — adults 65 and up and kids and adults with at least one medical condition that puts them at risk for severe illness — were exempted from the new requirement, meaning additional clinical trials aren’t needed.
Committee members grappled with a tough choice: recommend updating the vaccine, which could make it more effective but harder for healthy kids and adults to get, or stick with the current version, which might not work as well but would be easier for more people to access.
Read more: https://www.nbcnews.com/health/health-news/fda-panel-says-covid-vaccines-can-stay-fall-access-concerns-rcna208492
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