Last mentioned: Mar 25, 2026
Potential Launch
Anticipated commercial availability following regulatory approval and CDC recommendation.
Regulatory Filing
Expected submission of Biologics License Application (BLA) to the FDA.
Efficacy Results
Trial data shows over 70% efficacy against Lyme disease in endemic regions.
Regulatory Submission
Anticipated filing for FDA and EMA approval based on final trial data.
Efficacy Milestone
Trial results indicate efficacy exceeding the 70% threshold.
Phase 3 Launch
The VALOR trial begins enrolling thousands of participants in endemic areas.
Phase 3 Initiation
Pfizer and Valneva launch the VALOR Phase 3 clinical trial for VLA15.
Partnership Formed
Pfizer and Valneva enter a collaboration agreement to develop VLA15.
Pfizer and Valneva have reported positive Phase 3 results for their Lyme disease vaccine candidate, VLA15, demonstrating an efficacy rate exceeding 70%. This development marks a significant milestone in addressing the growing public health threat of tick-borne illnesses, potentially offering the first preventative vaccine for the disease in over two decades.
Pfizer and Valneva have announced that their Lyme disease vaccine candidate, VLA15, demonstrated more than 70% efficacy in late-stage clinical trials. This breakthrough marks the first successful human vaccine development for the tick-borne illness in over two decades, addressing a critical gap in public health.