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mRESVIA (mRNA-1345 / RSV vaccine)

Approved / Licensed

Developer: ModernaTX, Inc.  |  Target Disease: RSV

Category Resource

Explore licensed vaccines, adverse event reporting data, and history for this disease.

View RSV Vaccine Guide →
Development Phase Approved / Licensed Primary Status
Platform Technology mRNA Biologic Architecture
Target Indication RSV Pathogen / Antigen
Last Verified 2026-08-01 Tier 1 Multi-Source Checked

Multi-Jurisdiction Regulatory Status

Official licensing, rolling submissions, or authorization status tracked across major health authorities.

Regulatory Authority Status & Details
US FDA Approved / Authorized Date: 2024-05-31FDA approved for prevention of RSV-LRTD in adults 60+
EMA (Europe) Approved / Authorized Date: 2024-08-22EMA marketing authorization for adults 60+
Health Canada Approved / Authorized Date: 2024-09-18Health Canada authorized
TGA (Australia) Approved / Authorized Date: 2024-11-05TGA approved

Scientific Profile & Documentation

Platform Architecture
mRNA
Lead Developer
ModernaTX, Inc.
Next Expected Milestone
Global commercial distribution; expanded adult age-group trials
Analyst & Development Notes
Auto-grouped from 2 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
Primary Source Documentation
ClinicalTrials.gov NCT06067230 →
Additional Sources & Literature

Registered Clinical Trials & Studies

Direct registry links to active, completed, or pivotal registration studies across phases.

NCT06067230 Approved / Licensed

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in

Status: Active / Ongoing • Expected Readout: 2026-07-30
NCT05743881 Approved / Licensed

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Status: Active / Ongoing • Expected Readout: 2029-08-31

Milestone Overview

  • Stage Verification
    Approved / Licensed confirmed as of 2026-08-01.
  • Target Milestone
    Global commercial distribution; expanded adult age-group trials

Vaccine Data Navigator Candidate Profile Registry:

This candidate profile is indexed across all clinical development levels (Preclinical through Phase 1–3, Regulatory Filing, and Licensure) from primary registry databases (ClinicalTrials.gov, WHO ICTRP, FDA CBER, EMA, Health Canada, TGA Australia). Data are updated continuously to track global biologic and vaccine pipelines.