Moderna: expanded indication for RSV vaccine

Published: 2025-06-13 08:32:13 ET MRNA

Published on 06/13/2025 at 08:32

Moderna has announced that the FDA has approved 'mRESVIA' (mRNA-1345), its vaccine against respiratory syncytial virus (RSV), for the prevention of lower respiratory tract infections (LRTIs) caused by RSV in adults aged 18 to 59 at increased risk. This approval expands the indication already granted in May 2024 to people aged 60 and older.The decision is based on the results of a Phase 3 study (NCT06067230), which demonstrated a non-inferior immune response in adults aged 18 to 59 with comorbidities compared to the responses observed in those aged 60 and older. Comparable levels of neutralizing antibodies were found in the 18-49 and 50-59 age subgroups.The vaccine was generally well tolerated; the most common adverse reactions included injection site pain, fatigue, headache, myalgia, and arthralgia.As a result, Moderna plans to offer mRESVIA to adults aged 18 to 59 at risk and to those aged 60 and over starting in the 2025-2026 flu season in the US.Copyright (c) 2025 CercleFinance.com. All rights reserved.