Moderna, Inc. (NASDAQ:MRNA) said Thursday that a key U.S. Food and Drug Administration advisory committee voted unanimously in favor of the benefit-risk profile of its experimental seasonal influenza vaccine, clearing a major regulatory hurdle ahead of a final approval decision in August.
The FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC, voted 9-0 that the benefits of Moderna’s investigational flu vaccine mRNA-1010 outweigh its risks for preventing influenza in adults aged 50 to 64 and separately voted 9-0 in favor for adults aged 65 and older.
VRBPAC is an independent FDA advisory panel that reviews vaccine safety and efficacy data and provides recommendations before regulatory decisions. Its recommendations are non-binding, meaning the FDA still makes the final approval decision.
Key Regulatory Win
Moderna said the FDA’s Prescription Drug User Fee Act, or PDUFA, goal date for the vaccine remains Aug. 5, 2026.
"We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010," said Stéphane Bancel, chief executive officer of Moderna.
The company said the committee reviewed data from its Phase 3 clinical program, including results from the pivotal NCT06602024 trial, which were first announced in June 2025 and later published in The New England Journal of Medicine.
According to Moderna, the vaccine’s safety profile was consistent with previously reported studies.
The company submitted its biologics license application for mRNA-1010 in December 2025. Earlier this year, the FDA issued a refusal-to-file letter tied to questions around Moderna’s choice of comparator vaccine in trials, but briefing documents released ahead of Thursday’s meeting identified no major deficiencies.
Even if the FDA approves the vaccine, it would still need a recommendation from the Centers for Disease Control and Prevention’s advisory panel before broad public rollout.
Beyond COVID
mRNA-1010 is a trivalent mRNA-based flu vaccine, meaning it targets three influenza strains using the same messenger RNA technology that helped power Moderna’s COVID-19 vaccine.
Seasonal influenza remains a major public health burden, particularly among older adults, according to the Centers for Disease Control and Prevention, with seniors accounting for a disproportionate share of hospitalizations and deaths.
The panel vote comes as Moderna continues expanding beyond its COVID franchise and preparing for potential launches of additional respiratory products, including a flu-plus-COVID combination vaccine and a norovirus vaccine.
Price Action: MRNA shares rose 3.50% to close at $63.96 on Thursday, gaining $2.16 in regular trading. The stock slipped 0.055% in after-hours trading to $63.92.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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