India has granted market authorization to Takeda Biopharmaceuticals India’s QDENGA, the country’s first approved dengue vaccine. The vaccine, approved for individuals aged 4 to 60 years, does not require pre-vaccination screening, making it accessible to all eligible individuals, regardless of prior dengue infection. This approval is a significant milestone in India’s fight against dengue, a prevalent mosquito-borne disease.
Takeda’s QDENGA has been approved in 43 countries since its launch in 2022, with over 32 million doses distributed globally. In India, the vaccine’s approval is supported by data from a Phase III clinical trial, demonstrating its safety and immune response in individuals aged 4 to 60 years. The vaccine provides protection against all four dengue virus serotypes and dengue-related hospitalization over a seven-year follow-up period.
The vaccine, administered through two subcutaneous injections given three months apart, aims to protect against all dengue virus serotypes, irrespective of prior exposure. Goh Choo Beng, Medical Affairs Head for Takeda’s Southeast Asia and India Cluster, emphasized that this approval strengthens India’s comprehensive approach to dengue prevention, complementing existing public health measures like vector control and community awareness initiatives.
