---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-413168"
form_type: "8-K"
ticker: "PCVX"
cik: "0001649094"
company_name: "Vaxcyte, Inc."
filed_at: "2026-10-05T12:01:08+00:00"
generated_at: "2026-10-12T14:44:50.010891+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-413168
- form_type: 8-K
- ticker: PCVX
- cik: 0001649094
- company_name: Vaxcyte, Inc.
- filed_at: 2026-10-05T12:01:08+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649094/000119312526413168/0001193125-26-413168-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649094/000119312526413168/d21202d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-413168
- JSON: https://secwatch.observer/filing/0001193125-26-413168.json
- Plain text: https://secwatch.observer/filing/0001193125-26-413168.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.