An independent Food and Drug Administration (FDA) advisory panel votes to recommend approval of Moderna’s mRNA-based influenza vaccine for older adults. The panel’s recommendation comes after reviewers assessed the vaccine’s benefits and risks for adults in two age groups: people aged 50 to 64 and those 65 and older. According to reporting, the advisors voted unanimously, with a 9–0 result, concluding that the benefits outweigh the risks for the proposed use. Moderna’s product is described as an mRNA flu shot, branded as mFlusiva in one account, and the company is seeking FDA authorization for administration to the older-age population covered by the recommendation. The advisory panel’s action is a step in the regulatory process; FDA typically considers such recommendations as it moves toward a final decision on whether to approve the vaccine. If approved, it would mark a first availability of an mRNA-based flu vaccine for the older adults group addressed by the panel’s vote.
FDA advisory panel recommends Moderna’s mRNA flu shot for older adults
An independent Food and Drug Administration (FDA) advisory panel votes to recommend approval of Moderna’s mRNA-based influenza vaccine for older adults. The panel’s recommendation comes after reviewer...
- An FDA advisory panel recommends approval of Moderna’s mRNA-based flu vaccine for older adults.
- The panel vote is unanimous, reported as 9–0.
- The recommendation covers adults aged 50 to 64 and 65 and older.
- The panel concludes the vaccine’s benefits outweigh its risks for the proposed age groups.
- The recommendation is part of the FDA review process, preceding a final FDA decision.
A first-of-its-kind flu shot is a step closer to being available to the public after a Food and Drug Administration (FDA) advisory panel voted Thursday to recommend Moderna’s mRNA-based vaccine for approval. The FDA’s independent vaccine advisors voted unanimously 9-0 that the benefits outweigh the risks for Moderna’s mFlusiva shot in people ages 50 to 64 as well as 65 and older. Moderna is seeking...
8 hours agoA Food and Drug Administration advisory panel on Thursday recommended the approval of Moderna’s mRNA-based flu shot for older adults.
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