Overview
- The Drug Controller General of India granted market authorisation for Takeda’s QDENGA on Monday, allowing use in people aged 4 to 60 without requiring pre‑vaccination screening.
- QDENGA is a tetravalent, live‑attenuated vaccine given as two 0.5 ml subcutaneous doses three months apart and is designed to protect against all four dengue virus serotypes.
- Indian approval was based on Takeda’s global clinical programme and local data including the pivotal DEN‑301 (TIDES) trial and the Indian Phase III DEN‑302 study, which showed about 80% efficacy against confirmed dengue at 12 months and strong reductions in dengue‑related hospitalisation over follow‑up.
- Takeda has a manufacturing partnership with Hyderabad‑based Biological E. to scale production—plans cited capacity up to 50 million doses a year—and the company expects a private‑market launch in the first half of 2027 pending final supply, regulatory and commercial steps.
- The vaccine adds a new tool for India, which accounts for roughly one‑third of the global dengue burden and recorded more than 113,000 reported cases in 2025, but broader impact will depend on price, programme inclusion, supply contracts and ongoing safety and effectiveness monitoring.