CAMBRIDGE, Mass., June 20, 2026
Moderna, Inc. announced a major regulatory milestone for its investigational seasonal influenza vaccine mRNA-1010 after the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of the vaccine’s benefit-risk profile for adults aged 50 to 64 years and adults 65 years and older. The committee delivered a 9-0 vote in both age groups, signaling strong confidence in the clinical evidence supporting Moderna’s next-generation mRNA-based influenza vaccine candidate. The recommendation comes ahead of the FDA’s Prescription Drug User Fee Act (PDUFA) target action date of August 5, 2026, marking an important step toward potential approval of what could become one of the first widely available mRNA-based seasonal influenza vaccines. The decision further reinforces Moderna’s strategy to expand its mRNA platform beyond COVID-19 and into broader infectious disease prevention, addressing one of the most persistent global public health challenges.
Unanimous FDA Advisory Committee Vote Strengthens Approval Outlook
The positive VRBPAC recommendation was based on data from Moderna’s extensive Phase 3 clinical development program, including results from its pivotal Phase 3 study evaluating the safety and efficacy of mRNA-1010 in older adults. During the advisory committee meeting, experts reviewed comprehensive clinical evidence demonstrating that the vaccine’s benefits outweigh potential risks for preventing seasonal influenza in populations most vulnerable to severe disease. Influenza continues to result in significant hospitalizations and mortality worldwide, particularly among older adults who face a higher risk of complications.
The unanimous vote highlights confidence in Moderna’s ability to leverage its proven mRNA technology platform to develop innovative vaccines that address evolving public health needs. Although VRBPAC recommendations are non-binding, the FDA traditionally considers such expert guidance carefully during its final regulatory review process.
Phase 3 Data Demonstrate Strong Clinical Potential
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Clinical findings presented to the advisory committee included results from Moderna’s pivotal Phase 3 trial and supporting analyses recently published in The New England Journal of Medicine. The data demonstrated the potential of mRNA-1010 to serve as a differentiated non-egg-based influenza vaccine, offering an alternative approach to traditional flu vaccine manufacturing. Unlike conventional vaccines that often rely on egg-based production systems, Moderna’s mRNA platform enables rapid development and adaptation while maintaining consistency in manufacturing. The vaccine’s safety profile was reported to be consistent with findings observed in earlier studies of Moderna’s influenza vaccine program.
Researchers emphasized that the investigational vaccine may provide an important new option for seasonal influenza prevention, particularly among aging populations that experience the highest burden of influenza-related complications each year. The company believes that mRNA-1010 could help improve vaccine effectiveness and expand protection against circulating influenza strains.
Global Regulatory Momentum Expands Moderna’s Vaccine Portfolio
Beyond the United States, mRNA-1010 is currently undergoing regulatory review in the European Union, Canada, and Australia, with additional global submissions planned throughout 2026. The positive FDA advisory committee outcome strengthens Moderna’s position as a leader in mRNA medicine and demonstrates the growing versatility of its technology platform across multiple therapeutic and preventive applications. The company continues to advance a diverse pipeline spanning infectious diseases, oncology, rare diseases, and other critical healthcare areas.
If approved, mRNA-1010 would represent another major milestone in the evolution of mRNA-based vaccines and could significantly expand Moderna’s commercial vaccine portfolio. As regulators complete their assessments, healthcare stakeholders worldwide will be closely watching the August 2026 FDA decision, which could introduce a new era of mRNA-powered influenza prevention and provide healthcare providers with an innovative tool to reduce the annual burden of seasonal flu among older adults.
Source: Moderna press release
