The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Thursday, June 18, to discuss approval of Moderna Inc.’s (NASDAQ:MRNA) experimental mRNA-based flu vaccine.
FDA Advisory Committee To Review Moderna Flu Vaccine Application
The company submitted an application in December 2025 for mFlusiva (mRNA-1010), an mRNA-based trivalent influenza vaccine.
The VRBPAC panel’s vote will focus on the risk-benefit profile of mFlusiva for influenza prevention in adults aged 50 to 64 years, and in the 65-year-and-older population.
The briefing document released on Tuesday identified no major deficiencies.
The primary efficacy analysis demonstrated that mRNA-1010 (TIV) met all prespecified sequential success criteria—noninferiority, superiority, and super-superiority—relative to the standard-dose (SD) comparator.
Questions Around Comparator Choice And Clinical Data
Investors should note that in February, the FDA issued a refusal-to-file letter regarding Moderna’s influenza vaccine, citing the choice of a standard-dose seasonal influenza vaccine as the sole reason for the refusal.
The VRBPAC members will consider whether the standard-dose flu vaccine used as the control was the most appropriate comparator. High-dose, recombinant, and adjuvanted flu vaccines are generally preferred for adults 65 and older.
The committee will also consider uncertainties around the vaccine's relative efficacy against influenza B/Victoria due to limited case numbers, whether a single flu season provides sufficient efficacy data in Moderna's study population, and whether immunogenicity can serve as a reliable surrogate endpoint for predicting mFluSiva's clinical benefit in older adults.
FDA Decision Timeline And Proposed Approval Strategy
Following a Type A meeting, the FDA assigned a Prescription Drug User Fee Act goal date of August 5 for mRNA-1010. It’s for adults aged 50 and older.
Moderna proposed a regulatory pathway based on age, seeking full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older, along with a postmarketing requirement to conduct an additional study in older adults.
Moderna Analyst Sees Opportunity But Flags Some Uncertainties
William Blair noted that the scope of Moderna's postmarketing commitments remains unclear. The company's willingness to fund potentially costly Phase IV studies are important given management's guidance to limit additional spending on its respiratory vaccine franchise.
Analyst Myles Minter said mFluSiva could become a meaningful driver of Moderna's revenue growth in 2027 if approved.
However, Minter maintained a Market Perform rating, citing the need for greater visibility into Phase 3 INTERPATH-001 data for intismeran in adjuvant melanoma, expected in 2026, which he views as a more significant long-term catalyst for the stock.
MRNA Stock Price Activity: Moderna shares rose 1.19% at $56.06 during premarket trading on Wednesday, according to Benzinga Pro data.
Photo: pcruciatti / Shutterstock
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