Clinical trialsCompany release

Vaxcyte's 31-valent pneumococcal vaccine VAX-31 meets all primary endpoints in Phase 3 adult trial

🇺🇸 Vaxcyte, Inc. (PCVX) · Wed 04 Nov 2026

Topline OPUS-1 data show noninferiority to PCV20 and PCV21 with comparable safety; serotypes 3 and 12F missed a stricter threshold against PCV21.

Vaxcyte has reported positive topline results from OPUS-1, a Phase 3 trial of its 31-valent pneumococcal conjugate vaccine candidate, VAX-31, in adults. The data were released on 4 November 2026 alongside the company's third-quarter results.

According to Vaxcyte, VAX-31 met all prespecified noninferiority endpoints against both PCV20 and PCV21, and its safety profile was comparable to those vaccines. The company also said that serotypes 3 and 12F did not meet the stricter threshold in the comparison with PCV21.

Vaxcyte plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration in the first half of 2028. Before that, it expects results from the OPUS-2 and OPUS-3 studies in the first half of 2027.

Separately, the company said its Phase 1 study of VAX-A1, a Group A Streptococcus vaccine candidate, will move to Stage 2 after a review by the data safety monitoring board (DSMB).

What it means for your team

  • Regulatory teams should note that the planned BLA depends on the OPUS-2 and OPUS-3 readouts, due in the first half of 2027, as well as on OPUS-1.
  • The serotype 3 and 12F results against PCV21 are likely to be a point of scrutiny in the full dataset, which has not yet been published.
  • Market-access teams tracking adult pneumococcal vaccination should note the stated BLA timeline of the first half of 2028.
  • Pharmacovigilance teams will find the safety characterisation only at topline level so far. The company describes it as comparable to the PCV20 and PCV21 comparators.

Company's press release (SEC filing): Vaxcyte, Inc. ↗

Article written by VigiEye from the official source (Vaxcyte, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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