Moderna has reported encouraging results from its late-stage trial of a new mRNA-based flu vaccine, showing it produces a stronger immune response than an existing vaccine. This progress sets the stage for approval of both the standalone flu shot and a combined Covid-19 and influenza vaccine.
Earlier this year, Moderna withdrew its application for the combined vaccine to include fresh efficacy data from the standalone flu vaccine’s phase three trial. The company plans to resubmit both applications later this year and expects regulatory approval by 2026, according to Stephen Hoge, Moderna’s chief research and development officer.
The trial involved over 40,000 adults aged 50 and above, with Moderna’s mRNA-1010 vaccine proving about 27% more effective than the comparator. It showed strong protection against key flu strains, including A/H1N1, A/H3N2, and B/Victoria, with consistent results across age groups and health backgrounds. Among those aged 65 and older, efficacy was slightly higher at 27.4%.
Moderna’s CEO, Stephane Bancel, called the results “a significant milestone” in reducing flu’s impact on older adults, especially given the recent severe flu seasons. The U.S. Centers for Disease Control and Prevention reported that the 2024-2025 flu season saw the highest hospitalisations related to flu in 15 years, with over 600,000 Americans admitted last year.
Moderna’s mRNA technology offers advantages such as faster development and potentially better protection compared to traditional vaccines. The combined Covid-flu vaccine aims to simplify immunisation, reducing healthcare burdens and improving patient uptake.
While Moderna leads competitors like Pfizer and Novavax in developing a combined vaccine, its shares have fallen over 30% this year amid shifting U.S. vaccine policies. Despite this, Moderna remains engaged with regulators and confident in a clear path forward.
If approved, Moderna’s vaccines could transform seasonal vaccination by protecting millions against both influenza and Covid-19 with a single shot.