Vaxcyte announced positive topline results from the OPUS-1 pivotal Phase 3 adult trial evaluating its 31-valent pneumococcal conjugate vaccine (PCV) candidate, VAX-31. The study met all prespecified co-primary immunogenicity endpoints in adults aged 50 and older, demonstrating noninferiority to PCV20 and/or PCV21 for shared serotypes and superiority for unique serotypes. It also met the primary immunobridging endpoint in adults aged 18-49 and showed a safety profile similar to comparators. These results serve as the cornerstone for a planned Biologics License Application (BLA) submission expected in the first half of 2028, following data from OPUS-2 and OPUS-3 trials anticipated in early 2027. Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect against bacterial diseases.
