A mosquito-borne viral infection spreading in the Americas and Europe, caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. As of September 2020, there were more than 3 million reported cases in the Americas1 and the economic impact is considered to be significant. 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 currently the most clinically advanced chikungunya vaccine candidate worldwide. It targets long-term protection following vaccination with a single dose.
- In December 2022, Valneva announced that it has completed completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above. This BLA submission follows final pivotal Phase 3 data in March 2022  and final lot-to-lot consistency results in May 2022 . If the FDA accepts the filing, the FDA will determine priority review eligibility along with the action due date upon which it will complete its evaluation.
- Additionally, a clinical study of VLA1553 in adolescents is also ongoing in Brazil, which may support future regulatory submissions in this group if VLA1553 is initially approved in adults. In December 2022, Valneva also reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination.
- Valneva’s chikungunya program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the EMA in 2020 [4,5,6]. Valneva currently plans to make additional regulatory submissions for VLA1553 in the second half of 2023.
Additional information about chikungunya:
- PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas
- Valneva press release: https://valneva.com/press-release/valneva-successfully-completes-pivotal-phase-3-trial-of-single-shot-chikungunya-vaccine-candidate/
- Valneva Press release: https://valneva.com/press-release/valneva-successfully-completes-lot-to-lot-consistency-trial-for-its-single-shot-chikungunya-vaccine-candidate/
- Valneva press release: http://valneva.com/press-release/valneva-awarded-fda-fast-track-designation-for-chikungunya-vaccine-candidate/
- Valneva press release: https://valneva.com/press-release/valneva-awarded-fda-breakthrough-designation-for-its-single-shot-chikungunya-vaccine-candidate
- Valneva press release: https://valneva.com/press-release/valnevas-chikungunya-vaccine-candidate-awarded-ema-prime-designation/