FDA Approves Moderna’s RSV Vaccine, Marking Its Second Commercial Product

1. FDA Approval: The US Food and Drug Administration (FDA) has approved Moderna's mRNA-based respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and older.
2. Second Commercial Product: This approval marks Moderna's second commercial product, following the COVID-19 vaccine Spikevax.
3. mRNA Technology: mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19, demonstrating the versatility of Moderna's mRNA platform.
4. RSV Protection: The vaccine protects against lower respiratory tract disease (LRTD) caused by RSV infection, which can be severe in older adults.
5. Phase III Trial: The approval is based on positive data from the Phase III ConquerRSV trial, which showed an 83.7% efficacy in preventing LRTD caused by RSV.
6. Single-Dose Pre-Filled Syringes: mRESVIA is the only RSV vaccine available in single-dose pre-filled syringes, designed to streamline administration and reduce errors.
7. Commercial Launch: Moderna plans to make mRESVIA available for the 2024/2025 respiratory virus season in the US.
8. Global Expansion: The company is also pursuing approvals for mRNA-1345 in other global markets.