The two-dose vaccine, approved for people ages 4 to 60, is designed to protect against all four serotypes of the dengue virus and can be administered regardless of prior dengue infection | Image used for representational purposes only | Photo credit: Stock Photo
The Drugs Controller General of India (DCGI) has granted marketing authorization to Takeda Biopharmaceuticals India’s QDENGA (TAK-003), making it the first dengue vaccine approved in the country, according to a press release issued by the company.
The vaccine has been approved for the prevention of dengue disease in people aged 4 to 60 years. QDENGA is a live-attenuated quadrivalent vaccine designed to provide protection against all four dengue virus serotypes and is administered as a two-dose regimen, with doses administered three months apart.
According to the company, the vaccine can be administered regardless of whether the person has had a previous dengue infection and does not require a pre-vaccination examination. The approval comes as dengue continues to pose a major public health challenge in India, where reported cases have increased nearly 11-fold over the past two decades. India accounts for nearly a third of the global dengue burden, although modeling studies suggest the actual number of infections is substantially higher than reported.
The approval is based on Takeda’s global clinical development program comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants in dengue-endemic and non-endemic regions.
The company’s pivotal Phase III TIDES (DEN-301) trial enrolled more than 20,000 participants in eight dengue-endemic countries. According to Takeda, the vaccine demonstrated 80.2% efficacy against virologically confirmed dengue 12 months after the second dose and 90.4% against dengue-related hospitalization at 18 months. The 4.5-year follow-up data showed 84.1% efficacy against dengue-related hospitalization, while the seven-year follow-up demonstrated sustained protection against dengue disease and dengue-related hospitalization across all four serotypes.
The approval in India was also supported by a Phase III clinical trial conducted among participants aged 4 to 60 years. The company said the study found the vaccine to be safe, well tolerated and immunogenic in children, adolescents and adults.
Takeda said QDENGA has been approved in 43 countries in Asia, Latin America and Europe, with more than 32 million doses distributed through public and private immunization programs. The vaccine is recommended by the World Health Organization for use in dengue endemic settings with high transmission and has also received prequalification from the WHO. It is currently included in the National Immunization Program of Brazil and is available through public programs in Argentina, Colombia and Indonesia.
The company said it would work with Indian regulatory authorities, public health stakeholders and healthcare providers to support the planning and availability of the vaccine in India.
Published – Jul 20, 2026 04:18 pm IST
