Valneva’s chikungunya vaccine wins Canada approval

Health Canada has approved Valneva’s (NASDAQ:VALN) single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

Ixchiq is the world’s only licensed chikungunya vaccine. Valneva (VALN) began commercializing the vaccine in the U.S. this year and plans to sell first doses in Canada in the fourth quarter of 2024.

This decision marks the second approval the company has received for Ixchiq following approval from the U.S. Food and Drug Administration (FDA) in November 2023.

Juan Carlos Jaramillo, chief medical officer of Valneva, commented, “This second approval marks another significant milestone toward introducing a preventative solution against chikungunya disease worldwide.”

The approval is based on data from a pivotal Phase 3 study, which showed a 98.9% seroresponse rate at 28 days with a single vaccination. This immune response was sustained for six months by 96.3% of participants, and was equally durable in younger and older adults.

The European Medicines Agency (EMA) also recently recommended marketing authorization of the vaccine in Europe, and a formal decision is expected in the third quarter of 2024.

Shares of the vaccine maker were up around 6% premarket on Monday.