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
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