FDA

mResvia now approved in adults ages 18 to 59 at increased risk for RSV disease

June 20, 2025

FDA approved mRESVIA (mRNA-1345) for the prevention of lower respiratory tract disease caused by RSV in individuals 18 to 59 years of age who are at increased risk for disease.

Efficacy

The expanded approval was supported by data from a phase 3 trial (NCT06067230) that evaluated the immunogenicity of the vaccine in adults ages 18 to 59 with at least one of the following underlying conditions: coronary artery disease and/or congestive heart failure, chronic lung disease, type 1 or type 2 DM. mResvia met the coprimary endpoints showing noninferior neutralizing responses for RSV-A and RSV-B relative to responses seen in adults ≥60 years of age in the phase 3 ConquerRSV trial (NCT05127434).

Safety

The most commonly reported adverse reactions (≥10%) in individuals 18 to 59 years of age were injection site pain, fatigue, headache, myalgia, arthralgia, chills, axillary swelling/tenderness, and nausea/vomiting.

Sources:

mResvia (mRNA-1345) [package insert]. Moderna. https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/36130c97-6fb0-4bea-9f2e-fb5be7a90729/36130c97-6fb0-4bea-9f2e-fb5be7a90729_viewable_rendition__v.pdf Revised June 2025. Accessed June 18, 2025.

Moderna receives US FDA approval for RSV vaccine, mResvia, in adults aged 18-59 at increased risk for RSV disease. [News release]. 2025. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-RSV-Vaccine-mRESVIA-in-Adults-Aged-1859-at-Increased-Risk-for-RSV-Disease/default.aspx