PFE · News · 20260814N

Regulatory Approval Milestones

PFIZER INC · 2026-08-14 · Importance 32 · Surprise 42 · In source text

The European Medicines Agency validated Pfizer and Valneva’s Marketing Authorization Application for PF-07307405, initiating the formal European review. The Lyme disease vaccine candidate targets six prevalent OspA serotypes and is supported by Phase 3 VALOR trial results showing more than 70% efficacy and favorable tolerability in individuals aged five years and older. Pfizer and Valneva are seeking to introduce the first Lyme disease vaccine in Europe, where the disease causes more than 100,000 cases annually.

Key facts

• The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, the Lyme disease vaccine candidate developed by Pfizer and Valneva. source
• Pfizer and Valneva are seeking to bring the first vaccine of its kind to Europe, addressing the over 100,000 annual cases of Lyme disease in the region. source
• The Phase 3 VALOR clinical trial showed over 70% efficacy in preventing Lyme disease in individuals aged five years and older for PF-07307405. source
• The Phase III VALOR trial data supporting the PF-07307405 application demonstrated over 70% efficacy and good tolerability. source
• The Pfizer/Valneva Lyme disease vaccine candidate PF-07307405 targets six prevalent OspA serotypes. source

Impact estimates