CAMBRIDGE, MA – June 30, 2025 – Moderna, Inc. (NASDAQ: MRNA) today announced positive results from a Phase 3 efficacy study (P304) for its seasonal influenza vaccine candidate, mRNA-1010. The study, conducted in adults aged 50 and older, found that mRNA-1010 achieved a relative vaccine efficacy (rVE) of 26.6% against influenza illness compared to a licensed standard-dose flu vaccine, meeting the study’s stringent superiority criterion.
Crucially, strong rVE was observed for all vaccine-included strains: A/H1N1 (29.6%), A/H3N2 (22.2%), and B/Victoria lineages (29.1%). In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%, confirming consistent efficacy across various subgroups.
“Today’s strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults. The severity of this past flu season underscores the need for more effective vaccines,” said Stéphane Bancel, CEO of Moderna. He highlighted the potential of mRNA-based flu vaccines to more precisely match circulating strains, support rapid responses to future pandemics, and pave the way for COVID-19 combination vaccines.
This study builds on a previous Phase 3 trial where mRNA-1010 demonstrated superior seroconversion rates and geometric mean titer ratios against all strains compared to both high-dose and standard-dose licensed vaccines.
The CDC reported that the 2024-2025 flu season saw a 15-year high in flu-related hospitalizations and outpatient visits, with over 600,000 Americans hospitalized, underscoring the urgent need for improved flu protection.
The P304 trial enrolled 40,805 adults aged 50 and older across 11 countries. Safety data was consistent with previous studies, with most solicited adverse reactions being mild (e.g., injection site pain, fatigue, headache, myalgia). No significant differences were observed in unsolicited adverse events or serious adverse events between the vaccine and comparator groups.
Moderna plans to present these data at an upcoming medical conference, submit them for peer-reviewed publication, and engage with regulators for filing submissions for mRNA-1010.
Source:
https://investors.modernatx.com/news/news-details/2025/Moderna-Announces-Positive-Phase-3-Results-for-Seasonal-Influenza-Vaccine/default.aspx
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