Qdenga becomes India's inaugural dengue immunization solution

New Delhi, July 20 – In a landmark move, the Drug Controller General of India has approved Qdenga, the first dengue vaccine to be licensed for use in the country. Takeda Pharmaceuticals India’s Qdenga is cleared for individuals between four and sixty years of age, with no prerequisite serology test required before administration.

The approval arrives as India battles one of the highest global dengue burdens, with all four serotypes of the virus reported in multiple districts. Takeda highlighted that Qdenga is already approved in 43 nations and over 32 million doses have been distributed since its 2022 launch.

The vaccine's licensure is based on a comprehensive global clinical program that enrolled more than 28,000 participants across Phase 1, Phase 2 and Phase 3 trials, covering both dengue‑endemic and non‑endemic populations. Indian regulators specifically reviewed data from the Phase 3 DEN‑302 trial conducted in the country, confirming a favorable safety profile and strong immune response in the 4‑to‑60 age group.

Longitudinal data spanning up to seven years demonstrate that Qdenga provides protection against dengue infection and prevents hospitalisation caused by any of the four circulating serotypes. The immunisation schedule comprises two sub‑cutaneous doses of 0.5 mL each, administered three months apart.

According to Takeda’s medical affairs leadership, the vaccine’s introduction will augment existing vector‑control measures, surveillance systems, and community‑awareness campaigns, thereby reinforcing India's integrated strategy to curb dengue transmission.