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Highlights
- MRNA receives FDA approval to expand mRESVIA use to adults aged 18–59 with chronic conditions.
- The company’s approval is based on Phase 3 trial data showing consistent immune response in younger adults.
- MRNA plans to make mRESVIA available for wider adult use in the 2025–2026 U.S. virus season.
Moderna, Inc. (NASDAQ: MRNA) based in Cambridge, Massachusetts, develops mRNA-based vaccines and therapeutics for infectious diseases, cancer, rare conditions, and autoimmune disorders.
The company announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its respiratory syncytial virus (RSV) vaccine, mRESVIA® (mRNA-1345). The vaccine is now authorized for use in adults aged 18 to 59 who are at increased risk for RSV-related lower respiratory tract disease (LRTD), extending its previous approval granted in May 2024 for individuals aged 60 and older.
The decision follows data submitted from Moderna’s Phase 3 clinical trial (NCT06067230), which evaluated the safety and immune response of mRESVIA in adults aged 18–59 with underlying health conditions that elevate the risk of severe RSV infection. The vaccine demonstrated comparable immune responses in this group to those observed in older adults during prior studies. Neutralizing antibody levels were consistent across the 18–49 and 50–59 age subgroups, meeting the non-inferiority criteria established for regulatory approval.
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