Valneva SE announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva?s single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults. There is currently no approved chikungunya vaccine for children and Valneva?s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine2 to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus.

Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents. The multicenter, prospective, randomized, observer-blinded, Phase 2 clinical trial is planned to enroll approximately 300 healthy children one to eleven years of age at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants will be randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants) or a control vaccine (60 participants).

Valneva was granted approval from the U.S. Food and Drug Administration (FDA) for its chikungunya vaccine IXCHIQ® in November 20233. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (Anvisa) with potential approvals in 2024.