Moderna’s mRNA flu vaccine has proved to be more effective than a standard flu vaccine in a Phase III trial.
In the study (NCT06602024), which enrolled more than 40,000 adults aged 50 and above, Moderna’s mRNA-1010 was 26.6% more effective compared to a comparator vaccine, which was GSK’s Fluarix or Alpharix.
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Influenza-like illness was observed in 411 of 20,179 recipients of mRNA-1010 (2.0%) and 557 of 20,124 recipients of the standard-dose comparator (2.8%).
Adverse events (AEs) were more frequent with mRNA-1010 than with the standard-dose comparator, with injection-site pain occurring in 65.8% compared to 29.8%, fatigue in 45.1% vs. 20.3%, headache in 37.8% vs. 18.0%, and myalgia in 35.4% vs. 11.6%.
Most reactions were mild to moderate and transient, with serious AEs being reported in 2.2% of the recipients of mRNA-1010 and 1.9% of patients in the comparator dose.
Data was published in the New England Journal of Medicine on 6 May.
Stéphane Bancel, CEO 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 our ongoing regulatory submissions. In addition to demonstrating superior relative vaccine efficacy compared to a standard-dose flu vaccine, our 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.”
FDA U-turn
This data follows the US Food and Drug Administration’s (FDA) U-turn on Moderna’s mRNA flu vaccine earlier this year. It had initially refused to review the drug in February, claiming there were issues with the control arm used in the study, which it said “does not reflect the best-available standard of care” in the US at the time of the Phase III trial.
The agency changed its mind less than a week later, agreeing to review the vaccine and setting a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 for 5 August 2026.
This agency’s change in stance closely followed a Type A meeting between Moderna and the FDA’s Center for Biologics Evaluation and Research (CBER), in which the agency agreed to review mRNA-1010 differentially for adults aged 50-64 and recipients aged 65 years or older upon Moderna’s suggestion.
Speaking after the FDA agreed to review Moderna’s vaccine, Stephanie Kurdach, infectious disease analyst at GlobalData, noted that mRNA-based vaccines like mRNA-1010 could be a “great advancement for the seasonal influenza vaccines market”.
“Influenza vaccines produced via mRNA technology will have a shorter production time than egg-based vaccines, cell-based vaccines, or recombinant vaccines. This decrease in production time means that the vaccines can be made closer to the start of flu season, thereby allowing for a better match to that season’s circulating influenza strains. In addition to advancing the seasonal influenza vaccines market, the potential FDA approval of mRNA-1010 would also stake Moderna’s claim in the seasonal influenza vaccines market,” Kurdach told Pharmaceutical Technology, sister publication to Clinical Trials Arena.
GlobalData is the parent company of Clinical Trials Arena.
mRNA-based vaccines have been under the regulatory spotlight in the US under the Trump administration, leading to the deprioritisation of their development by US Health Secretary, Robert F Kennedy Junior (RFK Jr). In August 2025, HHS terminated nearly $500m of funding for mRNA vaccine research.
