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Valneva's (VALN) CHIKV Vaccine Gets Health Canada's Approval
ValnevaValneva(US:VALN) ZACKSยท2024-06-24 16:31

Core Insights - Valneva SE has received approval for its single-dose chikungunya vaccine, IXCHIQ, from Health Canada, following similar approvals from the FDA and the European Medicines Agency [1][11][18] - The chikungunya virus, transmitted by Aedes mosquitoes, poses significant health risks, and the approval of IXCHIQ addresses an unmet medical need for travelers to endemic regions [2][4][10] Expanding Market Potential - Over 50 million North Americans, including approximately 7 million Canadians, travel to chikungunya-endemic regions annually, indicating a substantial market potential for IXCHIQ [4] - The approval positions Valneva to significantly impact the chikungunya vaccine market globally, with plans to launch in Canada in Q4 2024 [16][18] Addressing Global Health Challenges - The vaccine's approval is critical in combating the public health threat posed by chikungunya, especially as climate change increases the spread of Aedes mosquitoes [10][17] - Valneva's global strategy includes collaborations with CEPI and Instituto Butantan to enhance vaccine accessibility in low- and middle-income countries, supported by a funding agreement with CEPI [12] Efficacy and Durability - The pivotal Phase 3 study published in The Lancet showed a 98.9% seroresponse rate 28 days post-vaccination, with 96.3% of participants sustaining this immune response for six months [11]