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Moderna Announces FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010, an Investigational Seasonal Influenza Vaccine
FDA Prescription Drug User Fee Act (PDUFA) goal date remains August 5, 2026 CAMBRIDGE, MA / ACCESS Newswire / June 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological ...
About this update from Moderna, Inc.
FDA Prescription Drug User Fee Act (PDUFA) goal date remains August 5, 2026 CAMBRIDGE, MA / ACCESS Newswire / June 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010, Moderna's investigational seasonal influenza vaccine, outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and voted 9-0 that the benefits of mRNA-1010 outweigh its risks for the prevention of influenza disease in adults 65 years of age and older. "We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010," said Stéphane Bancel, Chief Executive Officer of Moderna. "Influenza continues to cause substantial illness and hospitalizations among older adults each year. We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review." According to the U.S. Centers for Disease Control and Prevention (CDC), seasonal influenza remains a significant public health burden.[1] Older adults account for a disproportionate share of severe influenza outcomes, including hospitalizations and deaths. The VRBPAC discussion included data from Moderna's Phase 3 clinical program, including the primary analysis results from the pivotal Phase 3 clinical trial (NCT06602024), previously announced in June 2025 and recently published in The New England Journal of Medicine. These data further support the potential of mRNA-1010 to provide a differentiated non-egg-based option for influenza prevention in older adults. The safety profile of mRNA-1010 observed in the Phase 3 program was consistent with previously reported studies of Moderna's influenza vaccine candidate. The FDA will consider the recommendations of VRBPAC as part of its ongoing review of Moderna's Biologics License Application (BLA) for mRNA-1010. Advisory committee recommendations are non-binding, and the FDA is responsible for making the final approval decision. mRNA-1010 has been accepted for regulatory review in the United States, European Union, Canada and Australia. ...