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# Merck’s Pneumococcal 21-Valent Vaccine Approved
- URL: https://www.fdaweb.com/mercks-pneumococcal-21-valent-vaccine-approved/
- Published: 2024-06-18T12:00:00.000Z
- Updated: 2026-09-14T14:33:32.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157207

FDA has granted Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for:

- Preventing invasive disease caused by *Streptococcus pneumoniae* serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older;
- Preventing pneumonia caused by *S. pneumoniae* serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

Approval was based on immune responses as measured by opsonophagocytic activity, the company says, adding that continued approval may be contingent upon demonstration of clinical benefit in a confirmatory trial.