Shots:
- The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season
- Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower respiratory tract disease
- Trial met prespecified non-inferiority immunobridging criteria compared to adults (≥60yrs.) in P-III study, with comparable RSV-A & RSV-B antibody responses across both 18–49 & 50–59 age groups; data was presented at CDC ACIP 2025 & published in the Clinical Infectious Diseases
Ref: Moderna | Image: Moderna| Press Release
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