Regulatory filings are under review in the U.S., Europe, Canada and Australia, with potential approvals expected to begin in 2026

CAMBRIDGE, MA / ACCESS Newswire / May 6, 2026 / Moderna, Inc. (NASDAQ:MRNA) today 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%.

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.[1]

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.