Pfizer and Valneva Announce Positive Phase 2 Results for Lyme Disease Vaccine Candidate VLA15

Vaccine Development:
Pfizer and Valneva are collaborating on the development of VLA15, a vaccine candidate for Lyme disease, which is currently in Phase 2 clinical trials.

Phase 2 Results:
Recent Phase 2 trials have shown strong immune responses and favorable safety profiles in both pediatric and adult populations after a second booster dose.

Clinical Progress:
VLA15 is the most advanced Lyme disease vaccine candidate, with two ongoing Phase 3 trials, aiming to address the significant unmet medical need for Lyme disease prevention.

Lyme Disease Prevalence:
Approximately 476,000 individuals in the U.S. and 129,000 in Europe are diagnosed and treated for Lyme disease annually, highlighting the need for an effective vaccine.

Collaboration:
Pfizer and Valneva entered into a collaboration agreement in April 2020, with updates in June 2022, to co-develop VLA15.

Regulatory Pathway:
Subject to positive Phase 3 data, Pfizer plans to submit a Biologic License Application to the FDA and a Marketing Authorization Application to the European Medicines Agency in 2026.