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STAT+: Pharmalittle: We’re reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more

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Briefings

A working week briefing reports on Vaxcyte's experimental pneumococcal vaccine VAX-31, which demonstrated primary endpoints in a Phase 3 trial against 31 bacterial strains, surpassing Pfizer's 20 and Merck's 21. The company requires two additional trials before FDA approval, including one with an influenza vaccine and another in adults with prior pneumococcal shots. Concurrently, the FDA extended its review of Novo Nordisk's hemophilia A drug denecimig, which was submitted in September 2025 with an expected decision in Q3 2026, though the manufacturing facility issue remains unresolved.

Key points

• Vaxcyte's experimental pneumococcal vaccine VAX-31 achieved primary endpoints in a Phase 3 clinical trial, protecting against 31 serotypes of bacteria, surpassing Pfizer's 20 and Merck's 21 strains.
• Vaxcyte requires two additional trials before FDA approval: one involving an influenza vaccine and another in adults with prior pneumococcal vaccination history.

Context and limitations

The briefing covers Vaxcyte's Phase 3 trial results and Novo Nordisk's hemophilia A drug review status as of October 2026. Specific trial timelines, approval dates, and the exact nature of the manufacturing facility issue for denecimig are not fully detailed.

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