India approves first dengue vaccine QDENGA
Analysis based on 6 articles · First reported Jul 20, 2026 · Last updated Jul 21, 2026
The approval opens a significant market opportunity for Takeda in India, one of the world's highest dengue burden countries, and may boost revenues from vaccine sales. Local production by Biological E. could reduce costs and improve access, potentially expanding the vaccine market in India and other endemic regions.
India's India — Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for QDENGA (TAK-003), the country's first dengue vaccine, developed by Takeda Pharmaceutical Company. The vaccine is a live, attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes. It is approved for individuals aged 4 to 60 years, administered as two doses three months apart, and can be given regardless of prior dengue infection. The approval is based on extensive global clinical trials, including a Phase III study in India, and post-marketing surveillance showing a favorable safety profile. QDENGA has already been approved in over 40 countries and has received WHO prequalification. Takeda has partnered with Biological E. for local production in India, aiming to manufacture 50 million doses annually. The vaccine is expected to complement existing dengue prevention measures under the India — National Vector Borne Disease Control Programme.
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