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. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year with at least a further 130,000 cases in Europe3,4.

VLA15 – Valneva’s Lyme disease vaccine candidate

  • VLA15 is the only Lyme disease vaccine candidate currently in clinical development.
  • VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common pathogenic strains found in the United States and Europe.
  • Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022 [5].
  • Data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations [6,7].
  • In August 2022, Valneva and Pfizer initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15. The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older. The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States.
  • Pending successful completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.[8]
  • The VLA15 program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017 [9].

Additional information about Lyme disease:

Valneva’s press releases about 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/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html Accessed July 2022.
  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 and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15, Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15
  6. Valneva press release: Valneva Announces Positive Initial Results for Phase 2 Study of Lyme Disease Vaccine Candidate
  7. Valneva press release: Valneva Announces Positive Initial Results for Second Phase 2 Study of Lyme Disease Vaccine Candidate VLA15
  8. Valneva press release: Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15
  9. Valneva press release: Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15