In a major public health milestone, the Drug Controller General of India (DCGI) has approved Takeda’s QDENGA, making it the country’s first dengue vaccine available for individuals aged 4 to 60.
Published: July 20, 2026, 4:00 PM IST
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Dengue vaccine: In a historic breakthrough for public health, India’s drug regulator, the Drug Controller General of India (DCGI), has granted market authorization to Takeda’s QDENGA, approving the country’s first-ever dengue vaccine. Eligible for individuals aged 4 to 60, the tetravalent live-attenuated vaccine offers a crucial layer of defense against a disease that places a massive seasonal strain on the nation’s healthcare system. Unlike earlier dengue vaccines, QDENGA requires no prior blood testing or screening and can be administered regardless of whether a recipient has been previously infected, simplifying mass immunization efforts across the country.
What is the new Dengue vaccine?
The approval comes at a critical juncture for India, which accounts for nearly one-third of the global dengue burden and faces year-round co-circulation of all four dengue virus serotypes. Backed by extensive multi-year clinical trial data—including the Phase III trial conducted in India—QDENGA has demonstrated sustained efficacy in preventing both symptomatic infections and severe hospitalizations across all four strains.
Read more:
Dengue Vaccine in India: 5 Things to Know About The Vaccination Against Mosquito Borne Disease
India’s dengue prevention strategy
Takeda said the approval strengthens India’s dengue prevention strategy at a time when the country continues to bear one of the world’s highest disease burdens, with all four dengue virus serotypes circulating in several regions.
“Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India,” said Mahender Nayak, Head of Intercontinental Markets at Takeda.
How will government administer the new Dengue vaccine?
The company said the approval was supported by evidence from its global clinical development programme, comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic countries. The Indian regulator also considered data from the Phase III DEN-302 clinical trial conducted in India, which evaluated the vaccine’s safety and immune response among individuals aged 4 to 60 years.
According to Takeda, long-term follow-up data collected over seven years demonstrated that QDENGA continues to provide protection against dengue infection and dengue-related hospitalisation caused by all four virus serotypes.
The vaccine is administered as two subcutaneous injections of 0.5 ml each, given three months apart. Goh Choo Beng, Medical Affairs Head for Takeda’s Southeast Asia and India Cluster, said the vaccine is designed to protect against all four dengue virus serotypes regardless of previous exposure.
(With inputs from agencies)
