Moderna, Inc. (MRNA), the pharmaceutical major, Friday said that the FDA's Vaccines and Related Biological Products Advisory Committee has voted unanimously recommending the approval of MFLUSIVA, the company's investigational mRNA influenza vaccine.
MFLUSIVA, also known as mRNA-1010, is proposed for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine, in persons 50 years of age and older.
The FDA Advisory Committee voted 9-0 in separate age-group assessments that the benefits of MFLUSIVA outweigh its risks for influenza prevention in adults 50 through 64 years and those aged 65 years and older.
As per the U.S. Centers for Disease Control and Prevention or CDC seasonal influenza remains a significant public health burden and older adults account for a disproportionate share of severe influenza outcomes, including hospitalizations and deaths.
The FDA will consider the recommendations of the Advisory Committee before it makes its final decision on August 5, 2026.
"mRNA-1010 has been accepted for regulatory review in the United States, European Union, Canada and Australia. Moderna has received a U.S. FDA Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Regulatory submissions in additional countries are planned during 2026.", the company added.
On Thursday, MRNA shares closed at $64.01, up 0.08% on the Nasdaq.
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