Vaxcyte (PCVX) investor relations material

State of pneumococcal vaccination and VAX-31 program

• All three phase III studies for VAX-31 are fully enrolled, with pivotal OPUS-1 readout expected in Q4 this year.

• VAX-31 targets 31 serotypes, offering broader coverage than PREVNAR 20 (20 serotypes) and Capvaxive (21 serotypes).

• Direct head-to-head studies show VAX-31 elicits robust immune responses, often surpassing PREVNAR 20.

• Some serotypes (notably 22F, 3, 8, 23B, 31, 35B) may miss non-inferiority, but high immune titers are expected to support label inclusion.

• FDA precedent suggests near-misses on non-inferiority do not preclude label claims if immune responses are strong.

Regulatory and competitive landscape

• VAX-31 benefits from breakthrough and fast track designations, with constructive ongoing FDA dialogue.

• Pfizer has shifted focus to a preclinical 35-valent vaccine, but VAX-31 is expected to reach market first and cover 95% of circulating disease.

• GSK is developing a 30+ valent vaccine in early clinical stages; mixing multiple protein carriers has proven challenging for competitors.

• Post-marketing commitments will include a test-negative design study for effectiveness and extensive safety follow-up.

Clinical development and timelines

• OPUS-1 readout is expected in Q4 2024, with OPUS-2 and OPUS-3 in H1 2025; a manufacturing consistency study will follow.

• The manufacturing study will enroll about 1,500 subjects and can run in parallel with other studies, aiming for BLA filing late 2025.

• Safety database will exceed 3,000 subjects, meeting regulatory requirements.