Vaxcyte's VAX-31 hits all primary Phase 3 OPUS-1 endpoints in adults, setting up 2028 BLA

Vaxcyte, Inc.

VAX-31 met noninferiority (LBCI >0.667) for all 28 serotypes shared with PCV20/PCV21 in adults 50+; three VAX-31-unique serotypes plus cross-reactive 20B met superiority (LBCI >2.0).
In adults 18-49 vs 50-64, VAX-31 met noninferiority for all 32 serotype OPA GMR comparisons; well tolerated with safety profile similar to PCV20 and PCV21 across all ages.
Individual comparators: 20 of 20 serotypes vs PCV20 and 17 of 19 vs PCV21 met LBCI >0.667; serotypes 3 and 12F missed that bar but cleared the historical LBCI >0.5 threshold.
OPUS-2 and OPUS-3 Phase 3 results expected 1H 2027, supporting planned BLA submission in 1H 2028; management cites potential 13-36% incremental IPD coverage vs current adult PCVs.
CEO Grant Pickering says OPUS-1 validates the carrier-sparing platform; CMO Luis Jodar notes VAX-31 designed to combine coverage of circulating and historically important serotypes.

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