India approves first dengue vaccine amid rising disease burden | Today’s news
India has approved its first dengue vaccine, giving the Indian arm of Japanese drugmaker Takeda Pharmaceutical Co., Takeda Biopharmaceuticals India Pvt. Ltd, marketing authorization for QDENGA.
The Drug Controller General of India (DCGI) has approved the live attenuated vaccine for people aged 4-60 years under CT-20, New Drugs and Clinical Trials (NDCT) Rules 2019, Takeda India said in a statement on Monday.
QDENGA can be administered without prevaccination screening, regardless of previous dengue exposure.
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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 rapidly progress to serious, life-threatening complications requiring hospitalization.
The mosquito-borne viral disease dengue fever 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 modeling analyzes suggest that the true burden could be much higher, potentially amounting to tens of millions of infections each year. The disparity between reported cases and the likely extent of infection reflects the difficulty of tracking the disease, which is now widespread, with rapid urbanization and climate factors increasing pressure on health care systems.
Meanwhile, indigenous clinical candidates. including targeted vaccine development by domestic manufacturers such as Panacea Biotec, Bharat Biotech, Serum Institute of India and Indian Immunologicals remain in various stages of clinical trials as India looks to expand its future preventive arsenal.
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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 worldwide. Nayak said the company will work with public health authorities, health professionals and other partners to promote equitable and sustainable access to the vaccine in India.
“India carries a significant burden of dengue and all four serotypes of dengue virus have been documented to co-circulate in several areas.” said Dr. Goh Choo Beng, Head of Medical Affairs Southeast Asia and India, Takeda.
Choo Beng added that the approval of QDENGA will 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 program, which included 19 phase 1, 2 and 3 clinical trials with more than 28,000 participants in both endemic and non-endemic areas.
The pivotal phase III TIDES study (DEN-301) evaluated the vaccine in more than 20,000 participants in eight countries. At 12 months after the second dose, the study showed an overall vaccine efficacy of 80.2% against virologically confirmed dengue fever. 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 continued safety and efficacy for seven years.
The approval is also supported by data from a phase III clinical trial (DEN-302) in Indian participants aged 4-60 years. The study found QDENGA to be tolerated, safe and immunogenic in healthy adults, adolescents and children. These clinical results are further supported by the generation of real-world evidence and ongoing pharmacovigilance, the company said.
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QDENGA is a tetravalent, live attenuated vaccine designed to protect against all four dengue serotypes.
“The vaccine is administered subcutaneously as a 0.5 ml two-dose regimen three months apart. It has received WHO pre-qualification, which allows procurement through international agencies such as UNICEF. Globally, it is already included in public programs in countries such as Brazil, Argentina, Colombia and Indonesia. Following DCGI approval, Takeda will work with Indian regulatory authorities and healthcare providers in India to plan its supply and availability.”
