Merck’s Capvaxive: FDA Approves First Pneumococcal Vaccine Designed for Adults

1. FDA Approval: The FDA has approved Merck's Capvaxive, the first pneumococcal conjugate vaccine specifically designed for adults, to protect against invasive pneumococcal disease and pneumococcal pneumonia.
2. Broader Protection: Capvaxive covers 21 serotypes of pneumococcal bacteria, including eight strains not included in any other approved vaccine, providing broader protection than existing vaccines.
3. Market Impact: The vaccine is expected to be a significant growth driver for Merck, competing with Pfizer's Prevnar 20, which currently dominates the market.
4. Distribution: Capvaxive is anticipated to be available by late summer, pending CDC advisory committee recommendations.
5. Clinical Trials: The vaccine's approval is based on late-stage trials, including STRIDE-3, which compared Capvaxive to Prevnar 20 in adults 18 and older.
6. Pricing: The wholesale acquisition price of Capvaxive is set at $287 per dose.
7. Competitive Edge: Merck's vaccine is designed to capture a substantial market share due to its broader protection against strains not covered by other approved vaccines.