FDA Panel Votes 9-0 in Support of Moderna’s mRNA Flu Vaccine

Moderna has secured unanimous support from the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its investigational seasonal influenza vaccine, mRNA-1010. The committee voted 9-0 that the vaccine’s benefits outweigh its risks in adults aged 50 to 64 years and separately voted 9-0 in adults aged 65 years and older.

The recommendation represents a significant regulatory milestone as the FDA reviews Moderna’s Biologics License Application (BLA) for mRNA-1010. While VRBPAC recommendations are non-binding, they often play an important role in informing the agency’s final approval decisions.

Advancing mRNA Technology Beyond COVID-19

mRNA-1010 is Moderna’s seasonal influenza vaccine candidate built on the same messenger RNA platform used in the company’s COVID-19 vaccines. Unlike traditional egg-based influenza vaccines, mRNA technology enables rapid manufacturing and precise matching of vaccine strains to circulating influenza viruses.

Seasonal influenza remains a major public health challenge. According to the U.S. Centers for Disease Control and Prevention (CDC), older adults experience the highest rates of influenza-related hospitalization, severe complications, and death, making effective vaccination particularly important in this population.

Phase 3 Data Supported Advisory Committee Vote

VRBPAC reviewed evidence from Moderna’s Phase 3 influenza vaccine program, including results from the pivotal Phase 3 study (NCT06602024). The primary analysis from this trial was previously reported in June 2025 and later published in The New England Journal of Medicine.

The pivotal Phase 3 trial evaluated mRNA-1010 in adults aged 50 years and older and demonstrated superior relative vaccine efficacy against influenza compared with a licensed standard-dose seasonal influenza vaccine. The findings supported a favorable benefit-risk profile and formed the basis of Moderna’s BLA submission.

The committee also reviewed safety findings from the broader Phase 3 program. The safety profile was generally consistent with previous studies. Local and systemic reactions occurred more frequently than with some comparator influenza vaccines, but no new safety signals emerged that altered the committee’s overall assessment of the vaccine’s benefit-risk profile.

Advisory Committee Endorsement Strengthens Regulatory Outlook

Moderna Chief Executive Officer Stéphane Bancel said the committee’s vote reflects confidence in the clinical evidence supporting mRNA-1010. He noted that influenza continues to cause substantial illness and hospitalizations among older adults each year and highlighted the vaccine’s potential to expand seasonal flu prevention options.

The unanimous vote also reinforces Moderna’s broader strategy of extending its mRNA platform into respiratory infectious diseases beyond COVID-19. Success for mRNA-1010 could establish the company’s first approved standalone influenza vaccine and strengthen its position in the global respiratory vaccine market.

Regulatory Considerations

During the discussion, FDA reviewers highlighted higher rates of expected post-vaccination reactions with mRNA-1010 and stressed the need for ongoing safety surveillance after potential approval. Some panel members also noted that additional data comparing mRNA-1010 with high-dose or adjuvanted influenza vaccines could further clarify its role in adults aged 65 years and older. Despite these considerations, the committee unanimously concluded that the vaccine’s benefits outweigh its risks in both age groups.

Global Regulatory Progress

The FDA is expected to make a final decision on Moderna’s BLA by its Prescription Drug User Fee Act (PDUFA) target date of August 5, 2026.

In addition to the United States, regulatory authorities in the European Union, Canada, and Australia are reviewing applications for mRNA-1010. Moderna also plans additional regulatory submissions in other countries during 2026.

If approved, mRNA-1010 could become one of the first mRNA-based seasonal influenza vaccines available to older adults, offering a new non-egg-based option in a market long dominated by conventional flu vaccine technologies.

Reference

Moderna Announces FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010, an Investigational Seasonal Influenza Vaccine