mRESVIA FDA Approval History
Last updated by Judith Stewart, BPharm on June 13, 2025.
FDA Approved: Yes (First approved May 31, 2024)
Brand name: mRESVIA
Generic name: respiratory syncytial virus vaccine, mRNA
Dosage form: Injection
Company: Moderna, Inc.
Treatment for: RSV Vaccination and Immunization
mRESVIA is a modified RNA vaccine for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
- mRESVIA is indicated for active immunization for the prevention of LRTD caused by 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. - mRESVIA is a modified RNA vaccine that encodes for the RSV F glycoprotein which induces an immune response and the formation of antibodies against RSV pre-F protein.
- mRESVIA is administered as a single intramuscular injection, usually into the deltoid muscle of the upper arm.
- The most commonly reported (≥10%) adverse reactions:
- in individuals 60 years and older include injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%), and chills (11.6%).
- in individuals 18 through 59 years who are at increased risk for LRTD caused by RSV include injection site pain (73.9%), fatigue (36.9%), headache (33.3%), myalgia (28.9%), arthralgia (22.7%), chills (19.9%), axillary (underarm) swelling or tenderness (17.1%), and nausea/vomiting (10.8%).
Development timeline for mRESVIA
Further information
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