Takeda Biopharmaceuticals India Pvt. Ltd. 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.
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.”
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.