2020 Annual Business Report

Lyme disease – VLA15

Our lead program, VLA15, is a Phase 2 vaccine candidate targeting Borrelia, the bacterium that causes Lyme disease, under development in collaboration with Pfizer, and it is the only active vaccine candidate against Lyme disease currently undergoing clinical trials.

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 and Europe. VLA15 is the only vaccine undergoing clinical trials against Lyme disease.
  • Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA15 [1]. Valneva has reported positive initial results for two Phase 2 clinical trials of VLA15 in over 800 healthy adults.
  • As part of this collaboration, Valneva announced in December 2020 [2], that it had accelerated the pediatric development of VLA15 with an additional Phase 2 clinical trial anticipated to commence in March 2021. The dosing of the first subject in this trial will trigger a milestone payment from Pfizer of $10 million. Initial pediatric data are expected by mid-2022.
  • Together with Pfizer, Valneva expects that its Phase 3 clinical trial will start in the third quarter of 2022 to ensure administration of VLA15 in time for the pivotal, placebo-controlled field efficacy trial that the parties are planning for the 2023 tick season. Clinical readout, based on one tick season, is projected for end 2023.
  • If the results from these clinical trials are positive and, subject to regulatory approval, first licensure is anticipated for the first half of 2025. VLA15 has received Fast Track designation from the U.S.  Food and Drug Administration (FDA) [3].

[1] Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15

[2] Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidate

[3] Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15