Chikungunya – VLA1553

Valneva’s single-shot chikungunya vaccine – VLA1553 / IXCHIQ® 

  • IXCHIQ® was granted approval in the U.S. in November 2023 1,2 and in Canada and Europe in June 20243,4.
  • Regulatory reviews for IXCHIQ® are ongoing in the United Kingdom and Brazil.
  • A clinical study in adolescents, VLA1553-321, is ongoing in Brazil. The data are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years. The data are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations.
  • To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA15535. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019, which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program6.
  • Additionally, the Company initiated a Phase 2 pediatric trial in children aged 1 to 11 years, VLA1553-221, in January 20247 to support a Phase 3 pivotal pediatric study and potentially extend the label to this age group following initial regulatory approvals in adults and possibly in adolescents.

Valneva’s press releases about VLA1553

[1] Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[2] The vaccine is indicated in the U.S. for the prevention of disease caused by CHIKV in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

[3] Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[4] Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[5] Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries 

[6] CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine

[7] Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine – Valneva