2021 Annual Business Report

Chikungunya – VLA1553

VLA1553 is a single injection vaccine against chikungunya, a mosquito-borne disease that is highly prevalent in tropical and subtropical regions.

Chikungunya  – VLA1553

The strength of an integrated business model

Chikungunya is a mosquito-borne virus that has spread to more than 100 countries, with the potential to rapidly expand farther through infected travelers who carry the virus to their home countries.

  • There are no preventive vaccines or effective treatments available and VLA1553 is the first and only chikungunya vaccine candidate to report positive Phase 3 data.
  • Chikungunya is considered to be a major public health threat, with over three million cases reported in the Americas as of September 2020.
  • VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease. As a live-attenuated vaccine, VLA1553 is particularly well suited to target long-lasting protection, which differentiates from other chikungunya assets currently being evaluated in clinical trials.
  • In March 2022, Valneva successfully completed its pivotal Phase 3 trial [1]. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 2021 [2]. 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 trial 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 plans to seek licensure of VLA1553 based on a surrogate of protection agreed with the FDA and the EMA [3].
  • The sponsor of the first chikungunya vaccine to be approved in the United States will be eligible to receive a Priority Review Voucher [4].
  • In May 2020, Valneva partnered with the Instituto Butantan in Brazil to develop, manufacture and market VLA1553 in Low and Middle Income Countries. As part of this collaboration, Valneva initiated an adolescent clinical trial in Brazil in 2022. Valneva has been awarded up to $23.4 million in funding from CEPI in relation to this partnership.
  • VLA1553 has received Fast Track and Breakthrough Therapy designations from the FDA, as well as PRIME designation from the EMA.

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

[2] Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate

[3] The surrogate of protection is an immune response that predicts protection against clinical endpoints and is reasonably likely to predict protection from chikungunya infection. This eliminates the need to execute a time-intensive and costly field trial where a group of patients receiving a placebo is compared to groups of patients receiving VLA1553. The rates of infection are observed and compared at various points in time across each of the various trial groups.

[4] https://priorityreviewvoucher.org/