India granted market authorisation to QDENGA (TAK-003) on 20 July 2026 through the Drug Controller General of India. QDENGA became India’s first approved dengue vaccine and is approved for people aged 4 to 60 years.
Dengue and its causative agent
Dengue is a mosquito-borne viral disease caused by the dengue virus, which belongs to the genus Flavivirus. The virus has four serotypes, commonly designated DENV-1, DENV-2, DENV-3 and DENV-4.
QDENGA vaccine profile
QDENGA is a live-attenuated tetravalent vaccine developed by Takeda Biopharmaceuticals of Japan. A tetravalent vaccine is designed to provide protection against all four dengue virus serotypes. QDENGA can be given to individuals with or without previous dengue exposure. This feature removes the need for pre-vaccination screening or testing before administration.
Production, approval and global use
Takeda entered a partnership with Biological E in 2024 for vaccine manufacturing in India. Biological E has planned annual production capacity of 50 million doses. QDENGA has been approved in 43 countries since its launch in 2022, and more than 32 million doses have been distributed globally.
Important Facts for Exams
- Dengue is transmitted mainly by Aedes aegypti mosquitoes, which also spread chikungunya and Zika virus.
- India has reported more than 113,000 dengue cases in 2025, and the country accounts for nearly one-third of the global dengue burden.
- Live-attenuated vaccines contain weakened forms of the virus and are used in several immunisation programmes.
- Takeda Biopharmaceuticals is a Japan-based company, and Biological E is an Indian vaccine manufacturer.
Public health context
India has reported a more than 11-fold rise in dengue cases over the past two decades. Seven-year follow-up data for QDENGA has shown continued protection against dengue infection and hospitalisation across all four serotypes.
