secwatch.observer — SEC 8-K summary
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Issuer:     Vaxcyte, Inc. (PCVX)
CIK:        0001649094
Form:       8-K
Filed at:   2026-10-05T12:01:08+00:00
Accession:  0001193125-26-413168
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1649094/000119312526413168/0001193125-26-413168-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1649094/000119312526413168/d21202d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-413168

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