Valneva SE, a specialty vaccine company, has announced that the European Commission (EC) has approved its single-dose chikungunya vaccine, IXCHIQ®, for individuals aged 18 and above. This marks the third approval for the vaccine, following earlier approvals in the U.S. and Canada. The first doses are expected to be available in Europe in the fourth quarter of 2024.
IXCHIQ® is a groundbreaking vaccine as it is the world's first and only licensed vaccine against the chikungunya virus, a mosquito-borne disease that causes fever, severe joint pain, and other debilitating symptoms. This approval is particularly significant as climate change has led to the spread of the Aedes mosquito, the carrier of the chikungunya virus, to previously unaffected areas in Europe.
The vaccine's efficacy and safety have been demonstrated in a pivotal Phase 3 study, which showed a 98.9% seroresponse rate 28 days after a single vaccination, with sustained immunity in 97% of participants after 24 months. Further positive data in adolescents supports potential label extension for use in individuals aged 12 to 17 years.
Valneva has partnered with CEPI and Instituto Butantan in Brazil to enhance the vaccine's accessibility in low- and middle-income countries. The collaboration aims to address the global burden of chikungunya, particularly in regions where the disease is endemic.
This approval represents a crucial milestone in the fight against chikungunya, providing a much-needed vaccine solution for both travelers and local populations at risk of infection. Valneva's commitment to developing and commercializing vaccines for infectious diseases with unmet medical needs continues to make significant contributions to global public health.