Vaxcyte Reports Positive Phase 3 Topline Data for VAX-31 Vaccine Candidate

Vaxcyte announced positive topline results from its OPUS-1 pivotal Phase 3 trial for VAX-31, its 31-valent pneumococcal conjugate vaccine (PCV) candidate. The trial, which evaluated safety, tolerability, and immunogenicity in adults, successfully met all prespecified primary endpoints when compared against competitor vaccines Prevnar 20 (PCV20) and/or Capvaxive (PCV21). These results will form the basis for a future Biologics License Application (BLA) submission to the FDA.

Key Details

• Primary Endpoints Met: In adults 50 and older, VAX-31 demonstrated noninferiority for all 28 serotypes shared with PCV20 and/or PCV21 and superiority for its three unique serotypes.
• Safety Profile: The vaccine was well-tolerated and demonstrated a safety profile similar to that of PCV20 and PCV21 across all age groups studied.
• Regulatory Pathway: The company plans to report results from its OPUS-2 and OPUS-3 trials in the first half of 2027, supporting a planned BLA submission in the first half of 2028.