MRESVIA
STN: 125796
Proper Name: Respiratory Syncytial Virus Vaccine
Tradename: MRESVIA
Manufacturer: ModernaTX, Inc.
- MRESVIA is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in
- Individuals 60 years of age and older
- Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV
- Package Insert - MRESVIA
- Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (MRESVIA)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- August 7, 2026 Approval Letter - MRESVIA
- June 12, 2025 Approval Letter - MRESVIA
- December 23, 2024 Approval Letter - MRESVIA
- October 3, 2024 Approval Letter - MRESVIA
- June 14, 2024 Approval Letter - MRESVIA
- May 31, 2024 Summary Basis for Regulatory Action - MRESVIA
- Approval History, Letters, Reviews, and Related Documents - MRESVIA