Moderna, Inc. announced a publication in the New England Journal of Medicine of the positive Phase 3 study results evaluating mRNA-1010, its vaccine candidate for seasonal influenza. The peer-reviewed article summarizes the safety and efficacy data from Moderna's Phase 3 study (P304) evaluating the relative vaccine efficacy (rVE) of mRNA-1010 against influenza illness compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.
As previously reported, mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population. Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%). Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%.
"The publication of these peer-reviewed positive results in the New England Journal of Medicine reflects the strength of the clinical evidence supporting our ongoing regulatory submissions," said Stéphane Bancel, Chief Executive Officer of Moderna. "In addition to demonstrating superior relative vaccine efficacy compared to a standard-dose flu vaccine, our mRNA-based seasonal flu vaccine has the potential to more precisely match circulating strains and help reduce the substantial burden of disease caused by influenza in older adults."
According to the U.S. Centers for Disease Control (CDC), seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. More than 545,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work.
mRNA-1010 has been accepted for regulatory review in the U.S., Europe, Canada and Australia. Moderna has received a U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Regulatory submissions in additional countries are planned for 2026.
