Chikungunya – VLA1553

Chikungunya is a mosquito-borne viral infection spreading in the Americas and Europe, caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas and the economic impact is considered to be significant1. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically.

VLA1553 – Valneva’s single-shot chikungunya vaccine candidate

  • VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries. It has been designed by deleting a part of the chikungunya virus genome.
  • VLA1553 received U.S. FDA approval in November 2023 under the brand name IXCHIQ® and is indicated 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. Continued approval of IXCHIQ® in the United States is contingent upon verification of clinical benefit in confirmatory studies.
  • VLA1553 is also under accelerated assessment by the European Medicines Agency (EMA) and a standard regulatory review is underway with Health Canada.
  • The recent U.S. FDA approval2 was based on final pivotal Phase 3 data in 4,115 adults aged 18 years and above reported in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination4. The Lancet subsequently published these results in June 20235. Final lot-to-lot consistency results were published in May 20226, twelve-month persistence data in December 20227, and adolescent data in November 2023.
  • 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 VLA15538. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 20199, which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.

Additional information about chikungunya:

Additional information about VLA1553, including information about safety, is available in Valneva’s prior press releases and in the IXCHIQ® prescribing information, which is available on the FDA’s website.

Valneva’s press releases about VLA1553

[1] PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.

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

[3] Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

[4] Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

[5] Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet

[6] Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate

[7] Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate

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

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