India has approved its first dengue vaccine, LISTENdeveloped by Japanese drugmaker Takeda, marking a major milestone in the country’s fight against the mosquito‑borne disease.
The Drug Controller General of India (DCGI) granted approval under the New Drugs and Clinical Trials (NDCT) Rules, 2019, for use in individuals aged 4–60 years.
QDENGA offers protection against all four dengue virus serotypes and can be administered regardless of prior exposure, eliminating the need for pre‑vaccination testing. The vaccine is given subcutaneously in two doses, three months apart.
India, which accounts for nearly one‑third of global dengue cases, reported over 113,000 infections in 2025. Experts believe the actual burden could be far higher, underscoring the importance of preventive measures.
The approval is based on Takeda’s global clinical program involving 28,000 participants across 19 trials, including the pivotal Phase III TIDES study. Results showed 80.2% efficacy against confirmed dengue and 90.4% protection against hospitalisation at 18 months, with sustained safety and efficacy for up to seven years.
QDENGA has already been approved in 43 countries and received WHO pre‑qualification, enabling procurement through agencies such as UNICEF and PAHO. It is part of national immunisation programmes in Brazil, Argentina, Colombia, and Indonesia.
Takeda executives hailed the approval as a “new era in dengue prevention,” pledging collaboration with Indian health authorities to ensure equitable access.
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