Vaxcyte announces first participants dosed in OPUS Phase 3 trial of VAX-31

Vaxcyte (PCVX) announced that the first participants were dosed in the OPUS Phase 3 pivotal, noninferiority trial evaluating VAX-31 for the prevention of invasive pneumococcal disease, IPD, and pneumonia in adults. The design of the trial, which is expected to enroll approximately 4,000 participants, was finalized in consultation and alignment with the U.S. Food and Drug Administration, FDA. Topline safety, tolerability and immunogenicity results from the OPUS trial, which are expected to serve as the cornerstone of the VAX-31 Biologics License Application, BLA, are anticipated in the fourth quarter of 2026.