India gets its first dengue vaccine as DCGI clears Takeda's QDENGA
QDENGA vaccine, administered in two doses, is designed to protect people aged between four and 60 years against all four dengue virus serotypes
India has approved its first vaccine against dengue, marking a major milestone in the country's fight against one of its most persistent mosquito-borne diseases. The Drug Controller General of India (DCGI) has granted marketing approval to Takeda Biopharmaceuticals India's QDENGA, a two-dose vaccine designed to protect people aged between four and 60 years.
The approval is significant as India accounts for nearly one-third of the global dengue burden, with millions of infections estimated every year. Although official data recorded 121,824 dengue cases and 131 deaths in 2025, experts believe the actual number of infections is much higher because many cases go unreported. Surveillance data for 2026 has already shown a steady rise in infections, highlighting the continuing public health challenge.
QDENGA administration
Unlike earlier dengue vaccines, QDENGA can be administered regardless of whether a person has previously been infected with the virus. This eliminates the need for pre-vaccination screening, making it easier to deploy in dengue-endemic regions.
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QDENGA is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes. It uses a weakened Dengue Serotype-2 virus as its genetic backbone, with components from the remaining three serotypes engineered into the vaccine to generate broad immune protection. The vaccine is administered in two doses, given three months apart through a subcutaneous injection.
The vaccine has already been approved in 43 countries across Asia, Europe and Latin America and has received World Health Organization (WHO) prequalification, confirming that it meets international standards for quality, safety and efficacy. More than 32 million doses have been distributed globally, with countries such as Brazil incorporating it into their national immunisation programme.
Clinical evidence
The DCGI's approval is based on extensive clinical evidence generated through Takeda's global vaccine development programme involving more than 28,000 participants across 19 Phase I, II and III clinical trials. The pivotal Phase III TIDES trial, involving over 20,000 participants across eight countries, demonstrated an overall efficacy of 80.2 per cent against laboratory-confirmed dengue one year after completion of the two-dose schedule.
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The study also found that the vaccine reduced dengue-related hospitalisation by 90.4 per cent at 18 months, while long-term follow-up showed 84.1 per cent protection against hospitalisation even after 4.5 years. Data collected over seven years further indicated sustained protection and a favourable safety profile across all four dengue virus serotypes.
The approval was also supported by a separate Phase III clinical trial conducted in India among participants aged four to 60 years. The study found the vaccine to be safe, well tolerated and capable of producing a strong immune response in children, adolescents and adults.
Side effects
Most reported side effects have been mild and temporary, including pain or redness at the injection site, headache, muscle pain and fatigue lasting for a few days.
Health experts believe the approval represents an important addition to India's dengue control strategy, especially as rapid urbanisation, climate change and expanding mosquito habitats continue to fuel transmission. However, they emphasise that vaccination alone will not eliminate dengue. Continued mosquito control measures, disease surveillance, public awareness campaigns and early diagnosis will remain critical to reducing the country's disease burden.