- The approval comes at a critical time for public health, as reported dengue cases in India have increased 11-fold in the past two decades[1]
- Takeda's dengue vaccine (TAK-003) is the most extensively studied dengue vaccine, with long-term data demonstrating sustained protection against dengue disease and dengue-related hospitalization
NEW DELHI, July 21, 2026 /PRNewswire/ -- Takeda today announced that India's Drug Controller General of India (DCGI) has granted marketing authorization for Takeda's dengue vaccine (TAK-003) for the prevention of dengue disease in individuals 4 (four) to 60 (sixty) years of age. TAK-003 is India's first-ever approved dengue vaccine and was approved for use in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing.
Like many countries in South and Southeast Asia, dengue transmission in India is no longer confined to monsoon season. Several states report sustained year-round dengue transmissions expanding across both urban and rural areas. Reported cases exceeded 233,000 in 2024, but modeling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year.[2,3] With cases rising more than 11-fold in the past two decades and outbreaks growing more frequent and harder to predict, dengue is no longer a sporadic public health threat - it's an accelerating global challenge.
"Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest seven-year data for TAK-003 shows continued protection against dengue infection and hospitalization across all four serotypes; an important milestone for communities and health systems. Since its launch in 2022, TAK-003 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," said Dr. Mahender Nayak, Head of Intercontinental Markets, Takeda.
TAK-003's approval in India is supported by an extensive global clinical development program, including a local Phase 3 study as well as data from the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), the largest and longest efficacy trial conducted for a dengue vaccine. In the TIDES trial, TAK-003 demonstrated sustained protection against dengue and dengue‑related hospitalization and a favorable safety profile.
"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 TAK-003, 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," said Peter Streibl, Cluster General Manager, Southeast Asia and India, Takeda.
Since 2023, WHO's Strategic Advisory Group of Experts on Immunization (SAGE) endorsed the use of TAK-003 without the need for pre-vaccination screening.[4] Since then, TAK-003 has been recommended by the WHO for use in dengue-endemic settings, supporting its introduction in public immunization programs in areas with high transmission.[4] 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.[5]
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 TAK-003 in India.
In addition to India, TAK-003 is also approved in Indonesia, Thailand, Malaysia and Vietnam across the region. To date, TAK-003 has been distributed worldwide through public and private programs across Asia, Latin America and Europe, including Brazil's National Immunization Program and public programs in Argentina, Colombia and Indonesia.
About TAK-003 (Dengue Tetravalent Vaccine [Live, Attenuated])
TAK-003 is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four dengue virus serotypes and is designed to help protect against any of these serotypes.[6]
Please consult with your local regulatory agency for approved labeling in your country. Please consult with local healthcare professionals for information regarding the vaccine.
The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
References
- Baruah, Kalpana. (2021). DENGUE IN INDIA: TEMPORAL AND SPATIAL EXPANSION IN LAST TWO DECADES. https://www.researchgate.net/publication/352156283_DENGUE_IN_INDIA_TEMPORAL_AND_SPATIAL_EXPANSION_IN_LAST_TWO_DECADES
- National Center for Vector Borne Diseases Control. (2025). Dengue situation in India, 2021–2025. Ministry of Health & Family Welfare, Government of India. https://ncvbdc.mohfw.gov.in/index4.php?lang=1&level=0&linkid=431&lid=3715
- Wilder-Smith A, TAK-003 dengue vaccine as a new tool to mitigate dengue in countries with a high disease burden, The Lancet Global Health, 12, e179-e180. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(23)00590-9/fulltext
- World Health Organization, Vaccines and immunization: Dengue (2025). https://www.who.int/news-room/questions-and-answers/item/dengue-vaccines
- Takeda, New Phase 3 Data Show Takeda's Dengue Vaccine Delivers 7 Years of Sustained Protection Against Infection and Hospitalization (2025). https://www.takeda.com/newsroom/newsreleases/2025/dengue-vaccine/
- Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243
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Takeda's Dengue Vaccine (TAK-003) Becomes India's First Approved Dengue Vaccine, Bringing Prevention to One of the World's Most At-Risk Populations
Takeda's Dengue Vaccine (TAK-003) Becomes India's First Approved Dengue Vaccine, Bringing Prevention to One of the World's Most At-Risk Populations
