Vaxcyte, Inc. (PCVX) is advancing both its adult and infant programs for VAX-31, a 31-valent pneumococcal conjugate vaccine candidate that represents the broadest-spectrum in clinical development today, as the company moves toward a planned Biologics License Application.
A Next-Generation Approach to Pneumococcal Disease
Pneumococcal disease remains a major global health burden, causing invasive infections such as meningitis and bacteremia, as well as pneumonia and otitis media. Older adults and younger children face the highest risk, and rising antibiotic resistance has intensified the need for broader, more durable vaccine protection.
VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, is designed to expand coverage against both currently circulating and historically prevalent serotypes. The vaccine aims to increase protection to approximately 95% of invasive pneumococcal disease (IPD) and 88% of pneumococcal pneumonia in U.S. adults aged 50 and older, according to the company. In infants, VAX-31 is designed to cover roughly 92% of IPD and 96% of acute otitis media cases.
Progress in the Adult Clinical Program
Vaxcyte has dosed the first participants in OPUS-2, a Phase 3 study evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal-naïve adults aged 50 years and older. The trial is expected to enroll about 1,300 participants across U.S. sites and will assess safety, tolerability, and immunogenicity.
The company also plans to initiate OPUS-3, another Phase 3 study, in the first quarter of 2026. This trial will evaluate VAX-31 in adults who have previously received a pneumococcal vaccine, including PPSV23, PCV20, or other licensed options.
Meanwhile, OPUS-1, the pivotal Phase 3 noninferiority trial evaluating VAX-31 for the prevention of IPD and pneumonia in adults, continues to enroll participants. Topline data from OPUS-1 are expected in the fourth quarter of 2026, with results from OPUS-2 and OPUS-3 anticipated in the first half of 2027.
Advancement in the Infant Program
Vaxcyte has completed enrolment in its Phase 2 dose-finding study evaluating VAX-31 in healthy infants. The study includes a primary immunization series at two, four, and six months of age, followed by a booster dose at 12-15 months. More than 900 infants have been enrolled, and all participants have received at least their first dose.
Topline safety, tolerability, and immunogenicity data from both the primary series and booster dose are expected either sequentially or together by the end of the first half of 2027.
Manufacturing Expansion and Long-Term Strategy
As part of its long-term U.S. manufacturing strategy, Vaxcyte is preparing to begin the buildout of a custom fill-finish line in North Carolina in the first quarter of 2026. This effort is tied to the company's previously announced commitment of up to $1 billion in domestic manufacturing and services. Vaxcyte has also established a dedicated presence in the state to support chemistry, manufacturing, and controls activities.
PCVX has traded between $27.66 and $93.77 over the past year. The stock closed yesterday's trading at $54.83, up 7.19%, and rose further in the overnight trading to $54.34, up 0.95%.
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