Vaxcyte(US:PCVX) Globenewswire·2025-12-08 12:00Core Insights - The article discusses the initiation of the OPUS Phase 3 trial for VAX-31, a new pneumococcal conjugate vaccine aimed at improving protection against invasive pneumococcal disease (IPD) and pneumonia in adults [2][5][12] Trial Design and Objectives - The OPUS trial is a pivotal, noninferiority study designed to evaluate the safety, tolerability, and immunogenicity of VAX-31 compared to current standard-of-care vaccines, PCV21 and PCV20 [2][3] - Approximately 4,000 participants will be enrolled, with topline results expected in Q4 2026, which will support a Biologics License Application (BLA) submission [2][5] - The primary immunogenicity objectives include demonstrating noninferiority and superiority of VAX-31 against the comparator vaccines for various serotypes [4][9] Vaccine Coverage and Efficacy - VAX-31 is designed to cover approximately 95% of IPD and 88% of pneumococcal pneumonia in U.S. adults aged 50 and older, with potential increases in coverage of 14-34% for IPD and 19-31% for pneumonia compared to existing vaccines [13][14] - The vaccine aims to maintain pressure on both currently circulating and historically significant serotypes, enhancing immune responses [2][6] Company Background and Technology - Vaxcyte, the company behind VAX-31, focuses on vaccine innovation and utilizes a carrier-sparing, site-specific conjugation technology to enhance vaccine efficacy [16][17] - The company is also developing other vaccine candidates, including VAX-24 for infants, which aims to cover more serotypes than any current infant PCV on the market [16][12] Anticipated Milestones - Key upcoming milestones include the announcement of topline data from the OPUS trial in Q4 2026 and the initiation of additional Phase 3 studies in 2026, with results expected in 2027 [10][15]