Valneva, a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. This decision marks the second approval the Company has received for IXCHIQ® following approval from the FDA in November 2023. 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.
IXCHIQ® is the world’s only licensed chikungunya vaccine available to address this unmet medical need. Every year, over 50 million North Americans, of which approximately 7 million Canadians1, travel to countries where chikungunya is endemic. Valneva began commercializing the vaccine in the U.S. this year and plans to sell first doses in Canada in the fourth quarter of 2024.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This second approval marks another significant milestone toward introducing a preventative solution against chikungunya disease worldwide. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas that were previously unaffected. The broader we can make this vaccine accessible, the better we will mitigate the burden of this debilitating illness, and we would like to thank our partner, CEPI, for supporting us in this endeavor.”
In addition to U.S., Canada and Europe, Valneva partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) 2 and Instituto Butantan in Brazil3 to make the vaccine more accessible to Low- and Middle-Income Countries (LMIC). The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 20194, which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program. A marketing authorization application is currently under review by the Brazilian Health Regulatory Agency (ANVISA) with potential approval in 2024.
Dr. Richard Hatchett, Chief Executive Officer of CEPI, commented: “Health Canada’s approval of IXCHIQ® represents another significant advance in the fight against the debilitating chikungunya virus. Accelerated by climate change, the size and frequency of chikungunya outbreaks are increasing, with hundreds of thousands of cases already reported so far this year in the Americas, South Asia, and Africa. This is why CEPI, with its partners Valneva and the European Commission, are working to expand access to the vaccine for everyone, including the world’s most vulnerable populations.”
Health Canada’s approval was based on data from the pivotal Phase 3 study which were published in The Lancet, one of the world’s leading peer-reviewed medical journal, and 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 adults5.
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