CAMBRIDGE, MA — May 6, 2026 — Leads & Copy — Moderna, Inc. (NASDAQ:MRNA) announced today the publication of positive Phase 3 study results in the New England Journal of Medicine for mRNA-1010, its vaccine candidate for seasonal influenza.
The peer-reviewed article summarizes 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 and older.
The company 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.
mRNA-1010 has been accepted for regulatory review in the U.S., Europe, Canada and Australia.
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.
Stéphane Bancel, Chief Executive Officer of Moderna, said the publication of these peer-reviewed positive results in the New England Journal of Medicine reflects the strength of the clinical evidence supporting ongoing regulatory submissions. Bancel added that in addition to demonstrating superior relative vaccine efficacy compared to a standard-dose flu vaccine, the 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.
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. 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%.
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna’s mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company’s values and mindsets, Moderna’s mission is to deliver the greatest possible impact to people through mRNA medicines.
Source: Moderna, Inc.
