VAX-31's 31-valent pneumococcal vaccine thesis hinges on Phase 3 non-inferiority and superiority data against Prevnar 20 and Capvaxive

Vaxcyte is a clinical-stage company developing VAX-31, a pneumococcal vaccine not yet approved, for invasive pneumococcal disease and pneumonia in adults.

VAX-31 is a 31-valent pneumococcal conjugate vaccine targeting invasive pneumococcal disease and pneumonia in adults, with all three Phase 3 OPUS trials now fully enrolled across 6,191 participants. The thesis resolves on whether OPUS-1 topline data demonstrate non-inferiority to Prevnar 20 and Capvaxive across shared serotypes with superiority on incremental serotypes, enabling a BLA submission. The primary competitive risk is Pfizer's Prevnar 20 and Merck's Capvaxive, which hold established formulary positions and prescriber inertia that a superior serotype profile alone may not displace.