India’s regulator granted market authorisation to QDENGA (TAK-003) on 20 July 2026. The vaccine is authorised for persons aged 4–60 years and is India’s first approved dengue vaccine.
Vaccine profile
- Type: Live‑attenuated tetravalent vaccine targeting DENV‑1 to DENV‑4.
- Administration: Licensed for ages 4–60 years; can be given irrespective of prior dengue exposure.
- Screening: No routine pre‑vaccination serological testing required.
- Durability: Seven‑year follow‑up data show sustained protection against infection and hospitalisation across serotypes.
Regulatory, production and rollout
- Regulator: Market authorisation granted by the Drug Controller General of India (DCGI) through CDSCO.
- Developer: Takeda Biopharmaceuticals (Japan); global authorisations began in 2022.
- Manufacturing in India: Partnership with Biological E announced 2024; planned annual capacity ~50 million doses.
- Global use: Approved in 43 countries; >32 million doses distributed globally.
Public health and epidemiology
- Vector: Dengue transmitted mainly by Aedes aegypti.
- Burden in India: >113,000 reported cases in 2025; India accounts for nearly one‑third of global dengue burden.
IASPOINT Booster Facts
- Vaccine class: Live‑attenuated vaccines contain weakened organisms to elicit immune response without causing disease.
- TRIPS/GI note: (Not applicable) Regulatory approvals follow national drug law and WHO prequalification processes where required.