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 July 22, 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 only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. It targets long-term protection following vaccination with a single dose.
- A Biologic License Application (BLA) is currently under priority review[2] by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) review goal date at the end of November 2023. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above. A regulatory application has also been filed with Health Canada [3].
- These regulatory submissions follow final pivotal Phase 3 data in March 2022 [4], final lot-to-lot consistency results in May 2022 [5] and positive twelve-month persistence data in December 2022 [6].
- The Company’s pivotal Phase 3 data for VLA1553 have been published in The Lancet, the world’s leading peer-reviewed medical journal.
- 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.
- 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 [7,8,9]. 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/fda-accepts-valnevas-chikungunya-vaccine-license-application-for-priority-review
- Valneva press release: https://valneva.com/press-release/valneva-files-for-chikungunya-vaccine-authorization-with-health-canada
- 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: https://valneva.com/press-release/valneva-reports-positive-12-month-antibody-persistence-data-for-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/