India Approves QDENGA Dengue Vaccine

Key facts

• The Drugs Controller General of India (DCGI) granted market authorisation to Takeda's QDENGA, the first dengue vaccine approved in India.
• QDENGA is indicated for individuals aged 4–60 years and can be administered without pre-vaccination testing, regardless of prior dengue exposure.
• The vaccine is a tetravalent live-attenuated formulation designed to protect against all four dengue virus serotypes.
• It is administered as a two-dose regimen (0.5 ml subcutaneous) with the second dose given three months after the first.
• Clinical trial data showed 80.2% efficacy against virologically confirmed dengue at 12 months and 90.4% efficacy against dengue-related hospitalisation at 18 months after the second dose.
• The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic settings and has granted it prequalification.
• India accounts for nearly one-third of the global dengue burden, with the disease endemic across most parts of the country.