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.

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