Vaxcyte, Inc. (PCVX) has initiated the OPUS Phase 3 pivotal, non‑inferiority trial for its VAX‑31 pneumococcal conjugate vaccine, enrolling approximately 4,000 adults aged 50 and older. The study, designed in collaboration with the U.S. Food and Drug Administration, will compare VAX‑31 directly with the current standard‑of‑care vaccines Capvaxive (PCV21) and Prevnar 20 (PCV20).
VAX‑31 targets 31 serotypes, covering roughly 95 % of invasive pneumococcal disease and 88 % of pneumococcal pneumonia in U.S. adults 50 +. This represents a 14‑34 % increase in IPD coverage and a 19‑31 % increase in pneumonia coverage versus existing vaccines, positioning VAX‑31 as a potential category‑killer in the adult pneumococcal market.
The trial will generate the safety, tolerability, and immunogenicity data required for a Biologics License Application. Vaxcyte expects topline results in the fourth quarter of 2026, with additional Phase 3 studies planned for 2026 and readouts in 2027, after which a BLA filing is anticipated.
CEO Grant Pickering said the start of the adult Phase 3 program marks a major milestone, “advancing toward potential licensure.” The company’s expanded Breakthrough Therapy designation, granted in May 2025 to include pneumonia prevention, underscores regulatory confidence and may accelerate the review process.
Vaxcyte is also investing in commercial readiness, having secured a fill‑finish facility in North Carolina through a partnership with Thermo Fisher Scientific valued at up to $1 billion. With approximately $2.8 billion in cash and equivalents as of June 2025, the company is well positioned to fund the trial and future commercialization.
The OPUS trial’s initiation signals a critical step toward VAX‑31’s potential approval and launch, potentially reshaping the pneumococcal vaccine landscape by offering broader protection to a large adult population.
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