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Moderna’s mRNA-1010 Flu Vaccine Outperforms Standard Shot and Advances Toward Approval

Regulators will review Moderna’s standalone flu vaccine application later this year based on Phase 3 results showing superior efficacy

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Overview

  • In a global Phase 3 trial of over 40,800 adults aged 50 and older, mRNA-1010 demonstrated 26.6% higher efficacy than a licensed standard-dose influenza vaccine
  • The candidate showed strong relative efficacy against key strains, with rVE of 29.6% for A/H1N1, 22.2% for A/H3N2 and 29.1% for the B/Victoria lineage
  • Safety and tolerability profiles matched previous findings, with most solicited adverse reactions reported as mild and no increase in serious adverse events
  • Moderna voluntarily withdrew its Covid-19–flu combination application in May to incorporate standalone flu data and now plans to resubmit both filings later this year
  • Regulatory decisions on the standalone flu shot and the revised combo vaccine are expected in 2026 after the 2024-25 season saw more than 600,000 U.S. flu-related hospitalizations