According to a statement issued by Takeda India on Monday, the DCGI approved QDENGA under the CT-20 category of the New Drugs and Clinical Trials (NDCT) Rules, 2019. The vaccine has been approved for individuals aged between 4 and 60 years.
QDENGA can be administered without pre-vaccination screening and is suitable regardless of an individual’s previous dengue exposure. The approval introduces a new preventive option in India, where there is currently no specific antiviral treatment for dengue and patients are primarily managed through symptom-based care. The disease can rapidly progress into severe and potentially life-threatening complications requiring hospitalization.
Dengue, a viral infection transmitted by mosquitoes, is reported in more than 125 countries worldwide. India contributes nearly one-third of the global dengue burden. Reported dengue cases crossed 113,000 in 2025; however, modelling analyses indicate that the actual number of infections may be significantly higher, potentially reaching tens of millions annually.
The difference between reported cases and estimated infections highlights the challenges in monitoring a disease that has become widespread. Rapid urbanization and changing climate conditions have further increased pressure on healthcare systems managing dengue outbreaks.
Meanwhile, indigenous dengue vaccine candidates developed by Indian manufacturers, including Panacea Biotec, Bharat Biotech, Serum Institute of India, and Indian Immunologicals, continue to remain in different stages of clinical trials as India works to strengthen its future dengue prevention capabilities.
According to Nayak, QDENGA has received approval in 43 countries since its launch in 2022, with more than 32 million doses distributed globally. Nayak said Takeda would work with public health authorities, healthcare professionals, and other stakeholders 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 for Southeast Asia and India Cluster at Takeda.
Dr. Goh Choo Beng added that QDENGA’s approval would complement existing dengue prevention strategies, including mosquito control measures, disease surveillance, and community awareness initiatives.
Takeda stated that the Indian approval was based on its global clinical development programme, which included 19 Phase 1, Phase 2, and Phase 3 clinical trials involving more than 28,000 participants from dengue-endemic and non-endemic regions.
The key Phase III TIDES (DEN-301) trial evaluated the vaccine among more than 20,000 participants across eight countries. Twelve months after the second dose, the study demonstrated an overall vaccine efficacy of 80.2% against virologically confirmed dengue. At 18 months, the vaccine showed 90.4% efficacy against dengue-related hospitalization.
After 4.5 years of follow-up, two doses of QDENGA demonstrated 84.1% efficacy in preventing hospitalization, with sustained safety and efficacy observed through seven years. QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes.
The vaccine is administered through a subcutaneous injection as a 0.5 millilitre two-dose regimen, with the second dose given three months after the first. QDENGA has also received World Health Organization prequalification, allowing procurement through international agencies such as UNICEF.
Globally, QDENGA has already been included in public vaccination programmes in countries including Brazil, Argentina, Colombia, and Indonesia. Following the DCGI approval, Takeda will collaborate with Indian regulatory authorities and healthcare providers to plan the vaccine’s delivery and availability in the country.
The approval of QDENGA represents a significant milestone in India’s dengue prevention efforts, providing a new tool to address the country’s growing disease burden while strengthening existing measures such as vector control, surveillance, and public health awareness.
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