A Comprehensive Monograph on the 15-Valent Pneumococcal Conjugate Vaccine (Vaxneuvance)

Executive Summary

The 15-valent pneumococcal conjugate vaccine (PCV15), marketed globally as Vaxneuvance, represents a significant advancement in the ongoing effort to prevent diseases caused by the bacterium Streptococcus pneumoniae. This report provides an exhaustive analysis of Vaxneuvance, covering its composition, mechanism of action, clinical development, safety profile, regulatory status, and its strategic position within the global pneumococcal vaccination landscape.

Developed by Merck, Vaxneuvance is designed to provide broader protection than its predecessor, the 13-valent pneumococcal conjugate vaccine (PCV13). It includes all 13 serotypes from PCV13 and adds two additional, epidemiologically significant serotypes, 22F and 33F, which have been responsible for a substantial portion of residual invasive pneumococcal disease (IPD) in both children and adults.[1]

The vaccine's approval was supported by a robust clinical development program involving both pediatric and adult populations. These trials consistently demonstrated that Vaxneuvance elicits an immune response that is non-inferior to PCV13 for the 13 shared serotypes. Critically, the studies also showed a statistically superior immune response for the two new serotypes (22F and 33F) and for serotype 3, a persistent cause of severe disease despite its inclusion in PCV13.[3] The safety profile of Vaxneuvance was found to be comparable to that of PCV13 across all age groups, a crucial factor for its widespread adoption.[6]