India approves first dengue vaccine QDENGA for individuals aged 4 to 60 years
The Drug Controller General of India (DCGI) has granted market authorisation to Takeda Biopharmaceuticals India's QDENGA (TAK-003), making it the first dengue vaccine approved in the country. The live-attenuated tetravalent vaccine is approved for individuals aged 4 to 60 years and is administered as a two-dose regimen three months apart. It can be given without prior dengue screening and protects against all four dengue virus serotypes. Approval is based on Takeda's global clinical programme including the Phase III TIDES trial, which showed 80.2% efficacy against virologically confirmed dengue 12 months after the second dose and 90.4% efficacy against dengue-related hospitalisation at 18 months. Follow-up data at 4.5 years showed 84.1% efficacy against hospitalisation. QDENGA has been approved in 43 countries, is WHO-recommended and prequalified, and is included in Brazil's National Immunization Program. India accounts for nearly one-third of the global dengue burden.
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