Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ®

Core Viewpoint - Valneva SE's IXCHIQ® vaccine is recommended for authorization to extend its use to adolescents aged 12 and older in the EU, marking a significant step in combating chikungunya virus (CHIKV) [1][2][4] Company Developments - Valneva received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for IXCHIQ®, which is already authorized for individuals 18 years and older since July 2024 [1][2] - The company plans to submit additional label extension applications to the U.S. FDA and Health Canada for the use of IXCHIQ® in adolescents [4] - Valneva has expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant to enhance vaccine access in low- and middle-income countries [5][6] Clinical Data - Phase 3 data indicated that IXCHIQ® induces a high immune response in 99.1% of adolescents, with a sustained immune response in 98.3% one year post-vaccination [3] - The vaccine was reported to be generally safe and well tolerated in adolescents aged 12 to 17 years [3][4] Market Context - Chikungunya virus has been identified in over 110 countries, with significant economic and medical burdens expected to grow due to climate change [10] - The World Health Organization (WHO) has recognized chikungunya as a major public health issue, highlighting the need for effective vaccines [10] Strategic Partnerships - Valneva signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ® in Asia, focusing on affordable pricing for public health markets in low- and middle-income countries [6][7] - The company also has a prior agreement with Instituto Butantan in Brazil for local vaccine development and distribution [7]