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# Merck Gets Breakthrough on Pneumococcal Vaccine
- URL: https://www.fdaweb.com/merck-gets-breakthrough-on-pneumococcal-vaccine/
- Published: 2022-04-14T12:00:00.000Z
- Updated: 2026-09-14T17:40:41.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151604

FDA has granted Merck a breakthrough therapy designation for V116, an investigational 21-valent pneumococcal conjugate vaccine. It is being evaluated for preventing invasive pneumococcal disease and pneumococcal pneumonia caused by *Streptococcus pneumoniae* serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. The designation was based on data from a two-part randomized, comparator-controlled, double-blind Phase 1/2 study. The company says Phase 3 clinical trials are planned for later this year.