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.
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