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# Merck Gains Breakthrough Status for Pneumococcal Vaccine
- URL: https://www.fdaweb.com/merck-gains-breakthrough-status-for-pneumococcal-vaccine/
- Published: 2019-01-30T12:00:00.000Z
- Updated: 2026-09-15T00:58:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143260

FDA has granted Merck a breakthrough therapy designation for its V114 investigational 15-valent pneumococcal conjugate vaccine, indicated for preventing invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for preventing IPD in adults. Both indications are currently being studied in Phase 3 clinical trials, according to the company.

The designation was made based on immunogenicity data from two studies. Study 005 was a Phase 1/2 trial evaluating the safety, tolerability and immunogenicity profiles of four different lots of a new formulation of V114 in healthy adults and infants. Study 008 was a proof of concept Phase 2 pediatric trial confirming results from Study 005 in a larger population of infants. “In both studies, V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines,” Merck says.