Takeda Biopharmaceuticals India Pvt. Ltd. today announced that the Drug Controller General of India (DCGI) has granted market authorization (CT-20, New Drugs and Clinical Trials (NDCT) Rules, 2019) for QDENGA, Takeda’s dengue vaccine for the prevention of dengue disease in individuals aged 4–60. QDENGA is the first dengue vaccine approved in India and can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing. This approval marks an important step in strengthening dengue prevention efforts in India, where the disease remains a significant public health challenge.
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 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.
Dr. Mahender Nayak, Head of Intercontinental Markets 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 hospitalization 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. This approval marks an important step forward in strengthening dengue prevention in India. Building on Takeda’s 245-year heritage and more than 70 years of vaccine expertise, we remain committed to working with public health authorities, healthcare professionals, and partners to support equitable and sustainable access.”
Millions of Indians remain at risk each year due to widespread endemicity, rapid urbanization and climate-related factors that drive mosquito proliferation. This has made dengue a year-round public health threat, with seasonal surges continuing to strain the healthcare systems. Dengue is also complex to manage, with no specific treatment. It can rapidly progress to severe, life-threatening complications requiring hospitalization and intensive care.
Peter Streibl, General Manager, Southeast Asia and India Cluster said, “Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals, and partners across South and Southeast Asia, not only to support access to QDENGA, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control, and community engagement. Our aim is to contribute to sustainable, evidence-based solutions that reflect the needs of each country.”
Dr. Goh Choo Beng, Medical Affairs Head Southeast Asia & India Cluster said, “India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. QDENGA is designed to protect against all four serotypes, regardless of prior exposure. Its 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.”
The approval in India is based on results from Takeda’s global clinical development program, 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 hospitalization, 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 hospitalizations. 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 individuals aged 4–60 years. 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.
QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection across all four dengue virus serotypes. The vaccine is administered subcutaneously 0.5 mL as a two-dose regimen, with doses given three months apart.
QDENGA is recommended by the WHO for use in dengue-endemic settings and supports its introduction in public immunization programs in areas with high transmission, without the need for pre-vaccination screening. The 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.
QDENGA has been approved in 43 countries across Asia, Latin America and Europe, including India, with more than 32 million doses distributed globally through public and private programs. It is included in Brazil’s National Immunization Program and available through public programs in Argentina, Colombia and Indonesia.
Following the approval by DCGI, Takeda will continue to collaborate with Indian regulatory authorities, public health stakeholders, and healthcare providers to support the planning, delivery, and availability of QDENGA in India.
