2021 Annual Business Report

Lyme disease – VLA15

VLA15 is the only vaccine in clinical development against Lyme disease, the most common tick-borne infection in the northern hemisphere.

Lyme disease – VLA15

The strength of an integrated business model

Valneva has developed VLA15, a vaccine candidate against Borrelia, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common strains found in the United States, Canada and Europe.

  • Valneva has completed recruitment and reported initial results for three Phase 2 clinical trials of VLA15 in 1,300 healthy participants, in which Valneva observed high levels of antibodies against all six strains of Borrelia.
  • In April 2020, Valneva announced a collaboration with Pfizer pursuant to which Pfizer will lead late phase development of VLA15. If VLA15 is approved, Pfizer will have sole control over its commercialization and Valneva will be eligible to receive milestone and royalty payments.
  • As part of the collaboration with Pfizer, Valneva announced in December 2020 that it had accelerated the pediatric development of VLA15 and expects to report first pediatric data in 2022.
  • A phase 3 pivotal, placebo-controlled field efficacy trial is expected to start in the third quarter of 2022 to ensure administration of VLA15 in time for the 2023 tick season
  • VLA15 has received Fast Track designation from the FDA.