Valneva Announces Positive Results for its Lyme Disease Vaccine

Phase 2 Study Results

According to Valneva's press release, the Phase 2 study (VLA15-221) of the Lyme disease vaccine candidate demonstrated a strong anamnestic immune response and a good safety profile. Six months after the administration of a third booster dose, antibody levels exceeded the initial levels across all age groups. The study indicated that a three-dose vaccination regimen, compared to two doses, maintained higher antibody levels. The results support a vaccination schedule of three doses with an annual booster dose.

Collaboration with Pfizer and Future Plans

In April 2020, Valneva signed a collaboration agreement with Pfizer for the development and commercialization of VLA15. Currently, two Phase 3 trials are underway for this vaccine, which is the most advanced against Lyme disease. According to Valneva, approximately 476,000 people are diagnosed and treated annually in the United States, while 132,000 cases are reported each year in Europe. Subject to positive Phase 3 results, Pfizer plans to submit marketing authorization applications in the United States and Europe in 2026.

The Urgency of a Lyme Disease Vaccine

Lyme disease is a systemic infection transmitted by infected Ixodes ticks, caused by the bacterium Borrelia burgdorferi. It is recognized as the most common vector-borne disease in the northern hemisphere. Without adequate treatment, the infection can lead to severe complications, including joint, cardiac, or central nervous system issues. The medical need for a vaccine is therefore pressing. Valneva's VLA15 is an experimental vaccine targeting the six OspA serotypes present in North America and Europe.