Global pharma powerhouse Moderna has delivered a major boost to its seasonal flu vaccine ambitions, publishing positive Phase 3 results for its mRNA-based candidate mRNA-1010 in the New England Journal of Medicine.

 

The peer-reviewed study details findings from a large Phase 3 trial (P304) in adults aged 50 and older, comparing the experimental mRNA vaccine against a licensed standard-dose seasonal influenza shot. The results show mRNA-1010 achieved a statistically significant edge, meeting the study’s most stringent superiority benchmark.

 

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.

 

The vaccine demonstrated consistent protection across all major flu strains included in the formulation: A/H1N1: rVE 29.6%; A/H3N2: rVE 22.2%; B/Victoria: rVE 29.1%.

 

Benefits held steady across patient subgroups, including those with higher risk factors and varying vaccination histories. In adults aged 65 and older, mRNA-1010 showed an rVE of 27.4%, reinforcing its performance in the most vulnerable population.

 

“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. 

 

“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.”

 

The timing is notable. According to the U.S. Centers for Disease Control and Prevention (CDC), the 2024–2025 flu season saw hospitalizations and outpatient visits hit a 15-year high, with more than 545,000 Americans hospitalized. The surge underscored both the health and economic burden of seasonal influenza.

 

Regulators are now reviewing mRNA-1010 in the United States, Europe, Canada, and Australia. Moderna has secured a US Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) target action date of August 5, 2026, with additional global filings expected throughout 2026.

 

If approved, the shot would mark a significant expansion of Moderna’s mRNA platform beyond COVID-19 into one of the world’s largest recurring vaccine markets.