Moderna has reported positive phase 3 results for its seasonal flu vaccine, mRNA-1010, which outperformed a standard-dose licensed influenza vaccine in adults aged 50 and older.
The study, known as P304, enrolled over 40,000 participants across 11 countries. The vaccine showed a 26.6% higher relative vaccine efficacy compared with the existing option.
Across all age groups, risk profiles and vaccination histories, the results were consistently strong. Adults aged 65 and over showed an rVE of 27.4%.
mRNA-1010 also performed well against specific strains, with rVE of 29.6% for A/H1N1, 22.2% for A/H3N2 and 29.1% for B/Victoria.
Moderna CEO Stéphane Bancel said: “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.”
He added: “An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic and pave the way for COVID-19 combination vaccines.”
Safety results were consistent with earlier phase 3 data. Most adverse reactions were mild, with injection site pain the most common local effect. Fatigue, headache and myalgia were the most reported systemic reactions.
There were no notable differences between groups in terms of unsolicited or serious adverse events.
Moderna plans to present these findings at a medical conference and publish them in a peer-reviewed journal. The company will also begin regulatory discussions about filing submissions for the vaccine.
