FDA Approves Merck’s Vaxneuvance in Infants and Children

Merck received approval from the U.S. FDA for an expanded indication for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) to include children 6 weeks through 17 years of age. 
 

VAXNEUVANCE is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. The approval follows the FDA’s Priority Review of Merck’s supplemental application. 
 

The approval was based on data from seven randomized, double-blind clinical studies assessing safety, tolerability and immunogenicity of VAXNEUVANCE in infants, children and adolescents. Clinical data from the pivotal study showed that immune responses elicited by following a four-dose pediatric series were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs).