Lyme Disease Vaccine Candidate Approaches Approval

Lyme disease has been a nationally notifiable condition in the United States since 1991 without a U.S. Food and Drug Administration (FDA) approved vaccine.

Initially identified in Lyme, Connecticut, in 1976, over 63,000 cases of Lyme disease were reported by state health departments and the District of Columbia in 2022, primarily in the northeastern U.S.

However, based on the continued positive progress of an innovative multivalent protein subunit Lyme disease vaccine candidate, nature lovers may soon gain protection from this Black-legged tick-borne disease.

On July 17, 2024, Pfizer Inc. and Valneva SE announced that the participants of the Phase 3 clinical trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) had completed the primary vaccination series (three doses) of VLA15.

These study participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.

Subject to positive data, VLA15 could be the first Lyme disease vaccine to become commercially available.

In 2026, Pfizer plans to submit a Biologics License Application to the FDA and a Marketing Authorization Application to the European Medicines Agency.

Juan Carlos Jaramillo, M.D., Chief Medical Officer, Valneva, commented in a press release, “We are pleased to see the progress of our Phase 3 VALOR trial. Lyme disease is the most prevalent vector-borne disease in the United States and Europe."

"It can result in debilitating complications and extensive healthcare treatments. Given the growing burden, high medical need, and lack of effectiveness with current interventions, there is an urgent need for novel approaches to help prevent Lyme disease.”

Pfizer and France-based Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.