Approved Chikungunya Vaccine Reports Strong Immunity and Safety Data

The world's first and only licensed chikungunya vaccine today presented further positive pivotal Phase 3 data in adolescents.

On May 13, 2024, Valneva SE announced following the initial analysis up to Day 29 post-vaccination, the most recent analysis of study VLA1553-321 evaluated the safety and immunogenicity six months after vaccination with a single dose of the chikungunya virus (CHIKV) vaccine IXCHIQ®.

The Day 180 results confirm the initial positive immunogenicity and safety data Valneva reported previously and are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years.

The data are also expected to support the licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations.

The U.S. FDA approved IXCHIQ in November 2023, and the Centers for Disease Control and Prevention (CDC) recently adopted the Advisory Committee on Immunization Practices' recommendations on the use of the vaccine in the U.S.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release, "We are highly encouraged by these data, as they reinforce the strong immunity and safety observed in adults and the elderly, upon which FDA approval was granted."

"Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups. This broader accessibility can help provide protection and mitigate the burden of this debilitating illness."

Three marketing applications are under review by the European Medicines Agency, Health Canada, and the Brazilian Health Regulatory Agency, with potential approvals in 2024. 

The CDC recently issued an updated Level 2 Travel Health Advisory confirming chikungunya vaccination is recommended for adults traveling to a destination with a current CHIKV outbreak.