mFLUSIVA (mRNA-1010)
Influenza prevention · Adults aged 50 years and older
MRNA · Moderna, Inc.
监管认定
完整时间线
10 个里程碑FDA approved mFLUSIVA for adults aged 50 and older
FDA granted traditional approval for adults aged 50–64 and accelerated approval for adults aged 65 and older. mFLUSIVA became the first mRNA-based seasonal influenza vaccine approved in the United States; the accelerated-approval population is subject to confirmatory evidence requirements.
Moderna — mFLUSIVA FDA approval announcement↗VRBPAC voted 9–0 in favor
The FDA advisory committee voted 9–0 that the benefits of mRNA-1010 outweigh its risks in adults aged 50–64 and separately voted 9–0 for adults aged 65 and older. The PDUFA goal date remained August 5, 2026.
Moderna — VRBPAC vote and PDUFA update↗P304 results published in NEJM
The Phase 3 P304 trial showed 26.6% relative vaccine efficacy versus licensed standard-dose influenza vaccines in adults aged 50 years and older.
NEJM — Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults↗Revaccination analysis announced for ESCMID 2026
Moderna reported that sequential administration produced no increase in solicited adverse reactions and identified no new safety concerns. The analysis was scheduled for presentation at ESCMID on April 18, 2026.
Moderna — mRNA-1010 revaccination data at ESCMID 2026↗相关新闻
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