The Drug Controller General of India (DCGI) has approved Japanese company Takeda Biopharmaceuticals India’s dengue vaccine, Qdenga, making it the first such vaccine to be greenlighted in India. It is designed to protect against all four dengue virus strains (DENV-1, DENV-2, DENV-3 and DENV-4) and can be administered regardless of prior dengue exposure. It does not require pre-vaccination testing, the company said.The vaccine is administered subcutaneously. It comes as a two-dose regimen of 0.5 mL each, with doses given three months apart. The price has not been announced yet but since Takeda has entered into a manufacturing partnership with Hyderabad-based Biological E to produce up to 50 million doses annually, costs are expected to be competitive for the Indian market. Pricing will also depend on whether this gets incorporated into government immunisation programmes later.Also Read | Dengue is spreading fast: Can cutting-edge science outsmart it at last?The approval comes at a critical time for public health, with reported dengue cases in India increasing 11-fold over the past two decades.India continues to account for nearly one-third of the global dengue burden. Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 125 countries. India accounts for nearly one-third of the global dengue burden.In an official statement issued today, Dr Mahender Nayak, head of Intercontinental Markets, Takeda, said, “Dengue is a growing public health challenge and India needs sustained, evidence-based prevention.” The latest seven-year data for Qdenga show continued protection against dengue infection and hospitalisation across all four serotypes — an important milestone for communities and health systems.” Since its launch in 2022, Qdenga has been approved in 43 countries, with more than 32 million doses distributed globally.Dr Goh Choo Beng, Medical Affairs Head, Southeast Asia and India Cluster, said, “India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. The approval represents an important step in strengthening India’s comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures.”Also Read | Serum Institute of India ties up with DNDi for Phase III trial of dengue therapyWhat is the vaccine about?It is designed to protect against all four dengue virus serotypes. It is approved for use in the four to 60 year age group, regardless of previous dengue exposure, without the need for pre-vaccination testing.It is the most extensively studied dengue vaccine, with long-term clinical data demonstrating sustained protection against dengue disease and dengue-related hospitalisation.Story continues below this adWhat did clinical trials show?The approval in India is based on results from Takeda’s global clinical development programme, involving 19 Phase 1, 2 and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions. This included the pivotal Phase III TIDES (DEN-301) trial, which evaluated the vaccine in over 20,000 participants across eight countries over an extended period to evaluate both the long-term safety and efficacy of QDENGA. At 12 months following the second dose, the study met its primary endpoint, demonstrating an overall vaccine efficacy of 80.2% against virologically confirmed dengue (VCD).At 18 months, the study also demonstrated 90.4% efficacy against dengue-related hospitalisation, meeting a key secondary endpoint of the study. After 4.5 years, two doses of QDENGA provided 84.1% vaccine efficacy in preventing dengue-related hospitalisations. Notably, the vaccine has also shown sustained safety and efficacy for up to seven years across all four dengue virus serotypes.This approval is also supported by data from a Phase III clinical trial (DEN-302) conducted in Indian participants, which evaluated the safety and immunogenicity of the vaccine in the 4–60 age group. The study demonstrated that QDENGA was found 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 to deepen understanding of the vaccine’s safety and impact.WHO nodThe vaccine has also received WHO prequalification, confirming it meets global standards for quality, safety and efficacy, and enabling eligibility for procurement through international agencies such as UNICEF and PAHO to support wider access.Story continues below this adIn 2025, reported cases exceeded 113,000, but modelling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year.