PFE · Earnings call · 2026Q3T · Full report

Next-Generation Pneumococcal Vaccine

PFIZER INC · 2026-11-03 · Importance 30 · Surprise 24

Pfizer reported that pediatric PCV25 Phase 2 results met the historical twofold post-dose IgG criterion for all 20 serotypes shared with Prevnar 20. The company’s Phase 3 design incorporates a more stringent FDA noninferiority criterion, and its modeling predicts that criterion will be met for at least 22 of 25 serotypes. Pfizer aims to cover serotypes estimated to cause 84% of invasive disease in U.S. children under five, an estimated increase of approximately 25 percentage points versus Prevnar 20; its Phase 3 lot-to-lot study is fully enrolled. For adults, PCV35 extends the serotype 3 technology to other key serotypes, with a Phase 1 start expected that year.

Key facts

• Pfizer expects to start a Phase 1 study of adult PCV35 this year.
• Pfizer's Phase 3 modeling predicts the updated 1.5-fold noninferiority criterion will be met for at least 22 of 25 PCV25 serotypes.
• Pfizer's Phase 3 PCV25 lot-to-lot consistency study is fully enrolled.
• In pediatric PCV25 Phase 2, all 20 serotypes shared with Prevnar 20 met the historical twofold post-dose 1/post-dose 4 IgG criterion.
• Pfizer's pediatric pneumococcal vaccine aims to protect against serotypes causing an estimated 84% of invasive disease cases in U.S. children under five, an approximately 25-percentage-point increase versus Prevnar 20.