Pharma To Date

Pfizer and Valneva have released promising data from their phase 2 clinical trial of VLA15, a multivalent protein subunit vaccine developed to prevent Lyme disease. The vaccine targets six serotypes of Borrelia burgdorferi, the bacteria responsible for Lyme disease, which is transmitted through the bite of an infected tick. With no current vaccines available for Lyme disease, VLA15 represents a significant step forward in addressing a growing public health concern.

The phase 2 trial assessed the immune response and safety profile of a second booster dose administered a year after the first booster. The results revealed a strong anamnestic antibody response across all six serotypes covered by the vaccine, with a seroconversion rate exceeding 90% in all age groups. This suggests that the vaccine is effectively priming the immune system to respond to the infection, offering protection across different demographics, including children, adolescents, and adults.

Geometric mean titers, a key measurement of antibody levels, remained consistently high one month after both the first and second booster doses. Importantly, the safety profile of the vaccine did not change between the two booster doses, reinforcing the vaccine’s tolerability across all age groups.

Dr. Juan Carlos Jaramillo, Valneva’s Chief Medical Officer, emphasized the significance of these findings, noting that they support the potential benefit of booster doses in protecting against Lyme disease. He also reiterated the companies’ commitment to advancing the vaccine through clinical development, with the ultimate goal of offering protection to individuals in regions where Lyme disease is endemic.

Looking ahead, Pfizer and Valneva are preparing to file for regulatory approval with both the FDA and the European Medicines Agency in 2026. This timeline is based on data from two phase 3 trials, one of which has completed its primary vaccinations. Despite challenges that caused a delay in the original filing date, the companies remain optimistic about the vaccine's future. If successful, VLA15 could become the first approved vaccine for Lyme disease in decades.

As Lyme disease cases continue to rise, particularly in regions with high tick populations, the potential impact of VLA15 is substantial. The positive phase 2 results mark a critical milestone in the journey toward providing an effective vaccine for this increasingly prevalent disease.