The FDA granted Merck breakthrough therapy designation for its 15-valent investigational pneumococcal conjugate vaccine, V114.
The designation is for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in pediatric patients six weeks to 18 years of age. Merck’s V114 is also being developed for the prevention of the disease in adults.
The agency’s decision was based in part on immunogenicity data from two studies. In both studies, the vaccine induced an immune response in infants for two disease-causing serotypes not included in the currently approved vaccine.