India has officially approved its very first dengue vaccine as Takeda Biopharmaceuticals India Private Limited received market authorization from the Drugs Controller General of India (DCGI) for QDENGA. The vaccine is cleared for individuals aged 4 to 60 years to prevent dengue fever caused by any of the four viral serotypes. Notably, the vaccine can be administered regardless of a person’s prior dengue infection history and does not require any pre-vaccination screening test.
According to Takeda, the approval is supported by extensive global clinical trials involving over 28,000 participants across 19 studies, alongside phase 3 local clinical trial data evaluating its safety and immunogenicity in the Indian population. QDENGA is administered subcutaneously in a two-dose schedule, with a mandatory interval of at least three months between the doses. Global clinical data spanning seven years demonstrates that the vaccine consistently protects against dengue infections and significantly reduces hospitalization rates.
Dengue remains a major public health challenge globally, affecting more than 125 countries, with India accounting for roughly one-third of the world’s total dengue burden. Driven by rapid urbanization and favorable climate conditions for mosquito breeding, millions of Indians face annual health risks. Takeda’s leadership emphasized that this landmark approval, which aligns with World Health Organization (WHO) recommendations for endemic regions, marks a critical step forward in strengthening India’s comprehensive public health defense against vector-borne diseases.
