Moderna’s mRNA-Based RSV Vaccine, mRESVIA, Wins FDA Approval for Adults 60 and Older ###

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1. FDA Approval: The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based Respiratory Syncytial Virus (RSV) vaccine, mRESVIA, for adults aged 60 years and older.
2. Protection: mRESVIA is designed to protect against lower respiratory tract disease caused by RSV infection, which is a significant cause of morbidity and mortality in older adults.
3. Efficacy: The vaccine demonstrated an efficacy of 83.7% against RSV lower respiratory tract disease in a Phase 3 clinical trial, with continued protection over 8.6 months of median follow-up.
4. Administration: mRESVIA is available in single-dose pre-filled syringes, making it easier to administer and reducing the risk of administrative errors.
5. Market Competition: Moderna's vaccine enters a market already occupied by vaccines from GSK and Pfizer, with analysts predicting a significant market share for mRESVIA.
6. Revenue Expectations: Moderna expects net sales of about $4 billion in 2024 between its COVID and RSV vaccines, with mRESVIA contributing significantly to this revenue.
7. CDC Recommendations: An advisory panel to the Centers for Disease Control and Prevention (CDC) will convene in June to provide recommendations on the utilization and target population of Moderna's RSV vaccine.