India approves first dengue vaccine QDENGA

India's drug regulator, the India — Drugs Controller General of India (DCGI) under the India — Central Drugs Standard Control Organisation (CDSCO), has granted market authorization for Takeda Pharmaceutical Company's dengue vaccine QDENGA. This is the first dengue vaccine approved in India, indicated for individuals aged 4 to 60 years. The vaccine is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes and can be administered regardless of prior dengue exposure without pre-vaccination testing. The approval is based on a global clinical development program including 19 trials with over 28,000 participants, showing 80.2% efficacy against virologically confirmed dengue at 12 months and 90.4% efficacy against hospitalization at 18 months. India accounts for nearly one-third of the global dengue burden, with reported cases exceeding 113,000 in 2025. Takeda has partnered with Biological E. to manufacture up to 50 million doses annually in India. QDENGA has been approved in 43 countries and received WHO prequalification.