Vaxcyte (PCVX) Jefferies Global Healthcare Conference summary

Key clinical milestones and data readouts

• VAX-31 adult study fully enrolled with 1,000 subjects; top-line immunogenicity data expected in Q3 this year.

• VAX-24 infant study fully enrolled; first co-primary endpoint data expected in Q1 next year, second by year-end.

• Decision to advance VAX-24 or VAX-31 to Phase III will be based on upcoming VAX-31 data.

• Phase III studies for the chosen candidate to start between late 2024 and 2026, with readouts in 2027 and BLA filing soon after.

• VAX-24 infant data is highly anticipated due to the larger market size and potential for improved immune response.

Study design and immunogenicity assessment

• VAX-31 adult study uses a single-dose regimen compared to Prevnar 20, assessing functional antibody responses.

• Three VAX-31 dose levels (low, middle, high) are tested, all within the 1.1–4.4 microgram range.

• Carrier-sparing technology results in lower protein carrier content, potentially improving immune response, especially in infants.

• Immunogenicity success is defined by non-inferiority or mean GMR ≥0.6, with regulatory precedent allowing some missed endpoints.

• Data will be unblinded only at the end, with no interim immunogenicity data access by the team.

Manufacturing, regulatory, and commercial strategy

• Manufacturing partnership with Lonza expanded to support clinical and commercial supply, including a dedicated facility.

• Initial commercial launch planned from existing facilities, with global expansion following adult and infant approvals.

• ACIP recommendations and policy changes, such as lowering adult vaccination age to 50, could significantly expand the market.

• Competitive landscape favors broadest-spectrum vaccines; VAX-31 aims for 95–98% coverage of circulating strains.

• Additional pipeline includes a Group A strep vaccine and other protein-based candidates, with clinical guidance expected later this year.