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FDA Reconsiders Moderna's mRNA Flu Vaccine Application Following Revised Proposal

KVIA••CNN Newsource
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The FDA has decided to review Moderna's application for its new mRNA flu vaccine after initially rejecting it due to concerns about the adequacy of the clinical trial's control arm. Moderna has since proposed a revised regulatory approach, seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. If approved, the vaccine could be available for older adults in the 2026-2027 flu season, providing a new option for flu protection. Moderna's CEO expressed optimism about the FDA's engagement and the potential availability of the vaccine for seniors later this year.

Key Details: • FDA initially rejected Moderna's application due to trial concerns. • Moderna proposed a revised approach for different age groups. • Full approval sought for ages 50-64; accelerated approval for 65 and older. • Potential availability for the 2026-2027 flu season. • Moderna aims to provide a new flu protection option for seniors.

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