secwatch.observer — SEC 8-K summary
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Issuer:     Vaxcyte, Inc. (PCVX)
CIK:        0001649094
Form:       8-K
Filed at:   2023-04-17T23:59:59+00:00
Accession:  0001193125-23-102874
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vaxcyte reports positive Phase 2 data for VAX-24 in adults 65+; met key immunogenicity criteria vs Prevnar 20
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- VAX-24 2.2mcg dose met OPA non-inferiority for 18 of 20 serotypes common with Prevnar 20 and superiority for all four unique serotypes.
- Robust immune responses across all 24 serotypes at all doses in adults 65+, confirming prior Phase 2 results in adults 50-64.
- Full six-month safety data from both adult studies showed VAX-24 safety and tolerability similar to PCV20 with no related serious adverse events.
- Prespecified pooled analyses (age 50+ and 60+) showed VAX-24 2.2mcg met OPA non-inferiority for all 20 common serotypes and superiority for four unique.
- Company plans End-of-Phase 2 meeting with FDA in H2 2023; topline Phase 3 data in adults expected in 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1649094/000119312523102874/0001193125-23-102874-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1649094/000119312523102874/d492750d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-102874

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