India approves first dengue vaccine amid rising disease burden

India has approved its first dengue vaccine, giving Japanese drugmaker Takeda Pharmaceutical Co.'s Indian arm, Takeda Biopharmaceuticals India Pvt. Ltd, market authorization for QDENGA.

The Drug Controller General of India (DCGI) approved the live-attenuated vaccine for people aged 4-60 under the CT-20, New Drugs and Clinical Trials (NDCT) Rules, 2019, Takeda India said in a statement on Monday.

QDENGA can be administered without pre-vaccination screening, regardless of prior dengue exposure.

The approval marks a new step in dengue prevention in India, where there is no specific treatment for the disease and patients are treated based on symptoms. Dengue can also progress rapidly to severe, life-threatening complications requiring hospitalization.

A mosquito-borne viral disease, Dengue is found in more than 125 countries. India accounts for nearly one-third of the global dengue burden. Reported cases exceeded 113,000 in 2025, but modelling analyses suggest the actual burden could be far higher, potentially representing tens of millions of infections each year. The gap between reported cases and the likely scale of infection reflects the difficulty of tracking a disease that is now widespread, with rapid urbanization and climate factors adding to the pressure on healthcare systems.

Meanwhile, indigenous clinical candidates. including targeted vaccine developments by domestic manufacturers like Panacea Biotec, Bharat Biotech, the Serum Institute of India, and Indian Immunologicals, remain in various stages of clinical trials as India looks to expand its future preventative arsenal.

Seven years of data

“The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalization across all four serotypes; an important milestone for communities and health systems,” said Dr. Mahender Nayak, head of Intercontinental Markets, Takeda India.

According to Nayak, QDENGA has been approved in 43 countries since its launch in 2022, with more than 32 million doses distributed globally. Nayak said the company would work with public health authorities, healthcare professionals and other partners to support equitable and sustainable access to the vaccine in India.

“India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions.” said Dr. Goh Choo Beng, medical affairs head Southeast Asia and India Cluster, Takeda.

Choo Beng added that QDENGA's approval would complement existing dengue-prevention measures, including vector control, surveillance and community awareness.

The company said the Indian approval was based on Takeda’s global clinical development programme, which involved 19 phase 1, 2 and 3 clinical trials with more than 28,000 participants in endemic and non-endemic regions.

The pivotal phase III TIDES (DEN-301) trial evaluated the vaccine in more than 20,000 participants across eight countries. At 12 months after the second dose, the study showed overall vaccine efficacy of 80.2% against virologically confirmed dengue. At 18 months, efficacy against dengue-related hospitalization was 90.4%. After 4.5 years, two doses provided 84.1% efficacy in preventing hospitalization, with sustained safety and efficacy through seven years.

The approval is also supported by data from a phase III clinical trial (DEN-302) in Indian participants aged 4–60. The study found QDENGA to be tolerated, safe and immunogenic in healthy adults, adolescents and children. These clinical outcomes are further supported by real-world evidence generation and ongoing pharmacovigilance, the company said.

QDENGA is a tetravalent, live-attenuated vaccine designed to protect against all four dengue virus serotypes.

“The vaccine is administered subcutaneously as a 0.5 mL two-dose regimen, three months apart. It has received WHO prequalification, enabling procurement through international agencies like UNICEF. Globally, it is already included in public programs in countries like Brazil, Argentina, Colombia, and Indonesia. Following the DCGI approval, Takeda will collaborate with Indian regulatory authorities and healthcare providers to plan its delivery and availability in India,” the company said.