Chikungunya – VLA1553

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 have been more than 3 million reported cases in the Americas1 and the economic impact is significant (e.g. Colombia outbreak 2014: $73.6m2).

VLA1553 – Valneva’s chikungunya vaccine candidate

  • VLA1553 is currently the most advanced chikungunya vaccine candidate worldwide. It targets long-term protection following the administration of a single dose.
  • In March 2022, Valneva successfully completed its pivotal Phase 3 trial3. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 20213. The excellent immunogenicity profile was maintained over time, with 96.3% of participants showing protective CHIKV neutralizing antibody titers six months after receiving a single vaccination, and VLA1553 was confirmed to be highly immunogenic in elderly study participants. The six-month safety profile was also consistent with previous results across all age groups and VLA1553 was generally well tolerated among the subjects evaluated for safety.
  • Valneva now expects to commence the pre-submission process with the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.
  • The sponsor of the first chikungunya vaccine approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV).
  • VLA1553 has received Breakthrough Therapy and Fast Track designations designation from the FDA and PRIME designation from the EMA4,5,6.

Additional information about chikungunya:

  1. PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas
  2. Cardona-Ospina et al., Trans R Soc Trip Med Hyg 2015
  3. Valneva press release: https://valneva.com/press-release/valneva-successfully-completes-pivotal-phase-3-trial-of-single-shot-chikungunya-vaccine-candidate/
  4. Valneva press release: http://valneva.com/press-release/valneva-awarded-fda-fast-track-designation-for-chikungunya-vaccine-candidate/
  5. Valneva press release: https://valneva.com/press-release/valneva-awarded-fda-breakthrough-designation-for-its-single-shot-chikungunya-vaccine-candidate
  6. Valneva press release: https://valneva.com/press-release/valnevas-chikungunya-vaccine-candidate-awarded-ema-prime-designation/