Lyme Disease – LB6V (VLA15)

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Lyme disease is the most common vector-borne disease in the Northern Hemisphere1. It is caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks2. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 132,000 cases are reported annual in Europe from countries with surveillance systems.3,4

Lyme disease vaccine candidate LB6V (VLA15) partnered with Pfizer

  • There is currently no Lyme disease vaccine available on the market and LB6V is the most advanced vaccine candidate.
  • Pfizer and Valneva reported topline data for the placebo-controlled Phase 3 study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), demonstrating more than 70% efficacy in preventing Lyme disease in individuals aged five years and above. LB6V was also well tolerated with no safety concerns identified at time of analysis.
  • Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion (95% confidence interval lower bound >20) was not met in the first pre-specified analysis.
  • Given the clinically meaningful efficacy and the fact that statistical criterion was met in the second pre-specified analysis, Pfizer is confident in the vaccine’s potential and is planning submissions to regulatory authorities.
  • LB6V is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common pathogenic strains found in North America and Europe.
  • The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017 [5].

Additional information about Lyme disease:

Valneva’s press releases about LB6V (VLA15)

Scientific publications about Lyme and LB6V (VLA15)

    1. Lyme borreliosis in Europe: influences of climate and climate change, epidemiology, ecology and adaptation measures (2006), Retrieved from https://www.euro.who.int/__data/assets/pdf_file/0006/96819/E89522.pdf, Accessed 02-Oct-2021
    2. Stanek et al. 2012, The Lancet 379:461–473
    3. Center for Disease Control and Prevention. Lyme Disease. Data and Surveillance. April 2021. Available at: https://www.cdc.gov/lyme/data-research/facts-stats/index.html  Accessed October 2025.
    4. Sykes RA, et al. An estimate of Lyme borreliosis incidence in Western Europe. Journal of Public Health 2017; 39(1): 74-81
    5. Valneva press release: Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15