India approves first dengue vaccine QDENGA for people aged 4-60

Japanese drugmaker Takeda's QDENGA becomes the first dengue vaccine approved in India, marking a new era in dengue prevention. It provides protection against all four dengue virus serotypes.QDENGA is the first dengue vaccine approved in India and can be used in individuals regardless of previous dengue exposureThe Drug Controller General of India (DCGI) has approved Takeda Biopharmaceuticals India's dengue vaccine, QDENGA, for the prevention of dengue in individuals aged 4–60 years under the New Drugs and Clinical Trials (NDCT) Rules, 2019.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.ALL ABOUT QDENGA - INDIA'S FIRST DENGUE VACCINE APPROVEDQDENGA is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes. The vaccine is administered subcutaneously as a 0.5 mL 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 into public immunisation programmes in areas with high transmission, without the need for pre-vaccination screening. The vaccine has also received WHO pre-qualification, 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 programmes. It is included in Brazil’s National Immunisation Programme and is available through public programmes in Argentina, Colombia, and Indonesia.Dr. Mahender Nayak, Head of Intercontinental Markets, said, "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. This approval marks an important step forward in strengthening dengue prevention in India.”A NEW ERA IN DENGUE PREVENTIONMillions of Indians remain at risk each year due to widespread endemicity, rapid urbanisation, and climate-related factors that drive mosquito proliferation. This has made dengue a year-round public health threat, with seasonal surges continuing to strain healthcare systems.Dengue is also complex to manage, with no specific treatment. It can rapidly progress to severe, life-threatening complications requiring hospitalisation 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."Dr. Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster, added that 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.QDENGA APPROVAL BASED ON CLINICAL TRIALSThe 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 assess 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 individuals aged 4–60 years. The study demonstrated that QDENGA was well tolerated, safe, and immunogenic in healthy adults, adolescents, and children.These clinical outcomes are further supported by real-world evidence generation and ongoing pharma-covigilance to deepen understanding of the vaccine’s safety and impact.Following approval by the 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.- EndsPublished By: Devika BhattacharyaPublished On: Jul 20, 2026 12:51 IST