FDA Approves Moderna Flu Shot
Moderna’s mRNA flu vaccine won FDA approval for older adults after a rocky review.
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Updated Aug 6, 5:44pm ETEvery side, every morning
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The reporting
The FDA approved Moderna’s mFlusiva, the first U.S. seasonal influenza vaccine made with mRNA technology, for adults 50 and older. Moderna received traditional approval for adults ages 50 to 64 and accelerated approval for adults 65 and older, with a requirement to run an additional clinical trial in the older group. In a late-stage study, mFlusiva was about 27% more effective than a standard flu shot. The authorization follows an earlier FDA refusal-to-file decision and a unanimous June advisory committee vote backing approval.
Analysis & opinion
mRNA vaccine promiseMostly Left
mRNA vaccine technology remains scientifically valuable and could lead to better flu protection than traditional shots. Moderna’s flu vaccine is a meaningful advance, even if it is not the final goal of a universal flu vaccine.
political headwindsMostly Left
Trump administration health officials, especially Robert F. Kennedy Jr., have created obstacles for vaccine science through skepticism, intervention, cancellations, or weaker recommendations. That political pressure risks undermining mRNA progress and complicates the significance of Moderna’s FDA approval.
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