The US FDA Approves Moderna’s mFLUSIVA Against Seasonal Influenza for Adults Aged 50 or More

Shots: FDA approved mFLUSIVA against seasonal influenza for use in adults (≥50yrs); supply to select retailers to be available in coming wks. Regulatory review is ongoing in the EU, Canada & Australia, with flings in other countries planned during 2026 Approval in pts (50–64yrs.) was backed by a P-III trial (n=40,805; ≥50yrs.) assessing safety & reactogenicity of mFLUSIVA plus rVE vs a SD comparator against RT-PCR-confirmed protocol-defined influenza-like illness caused by influenza A/B strains Use in pts (≥65yrs.) received accelerated approval based on immunogenicity data from a P-III trial (n=2,992) vs a high-dose influenza vaccine, supported by descriptive rVE results from the P-III trial, with clinical benefit to be confirmed postmarketing Ref:  Moderna  |  Image: Moderna  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post The US FDA Approves Moderna’s mFLUSIVA Against Seasonal Influenza for Adults Aged 50 or More appeared first on PharmaShots.