India has granted regulatory clearance to its first-ever dengue vaccine, QDENGA (TAK-003), developed by the Japanese firm Takeda Pharmaceutical.
The Central Drugs Standard Control Organisation (CDSCO) approved the vaccine, marking a significant milestone in the nation’s public health efforts against the mosquito-borne disease.
The Drug Controller General of India (DCGI) issued the market authorisation under the New Drugs and Clinical Trials (NDCT) Rules, 2019. The vaccine is indicated for the prevention of dengue in individuals aged between 4 and 60 years.
A tetravalent live-attenuated vaccine, QDENGA is engineered to provide protection against all four serotypes of the dengue virus, reports India Today.
It is administered via two subcutaneous doses with a three-month gap between injections. Notably, the vaccine can be administered to individuals regardless of their prior exposure to the virus, eliminating the need for pre-vaccination screening.
The approval comes as India grapples with a substantial disease burden, representing nearly one-third of global dengue cases. Over the last two decades, reported infections in the country have surged 11-fold.
Although more than 1.13 lakh cases were documented in 2025, statistical models suggest the actual scale of infection is likely much higher.
Dr Mahender Nayak, Takeda’s head of Intercontinental Markets, emphasised that “growing public health challenge” in India necessitates sustained, evidence-based prevention.
He highlighted that data spanning seven years demonstrates the vaccine’s continued efficacy in preventing infections and hospitalisations across all virus serotypes.
According to Dr Goh Choo Beng, medical affairs head for the Southeast Asia and India Cluster, all four dengue serotypes have been found to co-circulate in various parts of India.
He noted that the vaccine’s introduction is a vital component of a “comprehensive approach” that includes vector control, community awareness, and surveillance. Peter Streibl, general manager for same cluster, described dengue as a “shared regional challenge” that demands cross-sector collaboration.
The clinical foundation for the approval includes 19 Phase I, II, and III trials involving over 28,000 participants. Specifically, the Phase III TIDES (DEN-301) trial, conducted with 20,000 participants in eight countries, reported an 80.2% overall efficacy one year after the second dose. The vaccine also showed 90.4% efficacy against hospitalisation at 18 months and 84.1% after 4.5 years.
Local safety and immunogenicity were confirmed through a Phase III trial conducted within India for the 4–60 age group.
Already prequalified and recommended by the World Health Organisation (WHO), QDENGA is approved in 43 countries. More than 32 million doses have been distributed worldwide, with the vaccine being integrated into national health programmes in Brazil, Argentina, Colombia, and Indonesia. Takeda has stated it will collaborate with Indian health authorities and providers to manage the vaccine’s domestic rollout.
