Core Viewpoint - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ®, for individuals aged 12 years and older, marking a significant milestone in addressing the chikungunya virus [1][3]. Company Developments - IXCHIQ® is now authorized for adults in Canada and has received an adolescent label extension in Europe [1]. - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, with similar durability across age groups [2]. - Valneva's Chief Medical Officer emphasized the importance of making the vaccine accessible to all age groups, especially in endemic regions [3]. - IXCHIQ® was the first chikungunya vaccine approved in an endemic country, receiving authorization from Brazil earlier this year [3][4]. Industry Context - Chikungunya is increasingly recognized as a public health issue, with recent outbreaks reported in Brazil, India, and China [3][5]. - The World Health Organization has identified chikungunya as a major public health problem, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5]. - Valneva's partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) aims to enhance access to IXCHIQ® in low- and middle-income countries [3][4][6].

Core Points - The FDA has lifted the recommended pause on the use of IXCHIQ for individuals aged 60 and older, following a thorough review by the European Medicines Agency (EMA) [1][2] - IXCHIQ is indicated for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years and older at high risk of exposure [1][2] - The product's prescribing information has been updated to include reports of serious adverse events, particularly among elderly individuals with multiple underlying health conditions [2][4] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] - Revenues from the commercial business support the advancement of the vaccine pipeline, including candidates for Lyme disease, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has caused significant outbreaks globally, with over 3.7 million cases reported in the Americas between 2013 and 2023 [6] - The World Health Organization (WHO) has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change [6]

Core Points - Valneva SE's chikungunya vaccine IXCHIQ has faced updated recommendations from France's Haute Autorité de Santé (HAS) due to serious adverse events reported in elderly individuals with comorbidities during the vaccination campaign in La Reunion and Mayotte [1][2] - The French health authorities have suspended the use of IXCHIQ for individuals aged 65 and older while maintaining its recommendation for those aged 18 to 64 [2] - Valneva has supplied 40,000 doses of IXCHIQ to La Reunion amid a significant chikungunya outbreak with approximately 40,000 confirmed cases since the start of 2025 [1][4] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record in advancing vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [8] - Valneva's revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [6] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, highlighting the need for effective vaccines and interventions [6]