NEW DELHI, India — Takeda has achieved a major public health milestone after India’s Drug Controller General of India (DCGI) granted marketing authorization for its dengue vaccine, TAK-003, making it the country’s first approved vaccine for dengue prevention.
The approval comes at a crucial time as dengue cases continue to surge across India. Once largely associated with the monsoon season, dengue transmission has become a year-round threat in many parts of the country, affecting both urban and rural communities. Reported dengue cases surpassed 233,000 in 2024, while health experts estimate that the actual number of infections could reach tens of millions annually. Over the past two decades, reported cases have risen more than elevenfold, underscoring the growing urgency for effective prevention strategies.
TAK-003 is approved for individuals aged four to 60 years and can be administered regardless of prior dengue infection status, eliminating the need for pre-vaccination screening. The vaccine’s broad eligibility is expected to simplify its deployment and improve access for populations at high risk of dengue infection.
The vaccine is currently the most extensively studied dengue vaccine globally, backed by long-term clinical data demonstrating sustained protection against dengue disease and dengue-related hospitalizations. Its efficacy has been evaluated over seven years, including protection against all four dengue virus serotypes.
“Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention,” said Dr. Mahender Nayak, Head of Intercontinental Markets at Takeda.
“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.”
Takeda’s dengue vaccine approval in India is supported by an extensive global clinical development program, including a local Phase 3 study and the pivotal Tetravalent Immunization against Dengue Efficacy Study (TIDES)—the largest and longest efficacy trial conducted for a dengue vaccine. The study demonstrated sustained protection against dengue and dengue-related hospitalizations, while maintaining a favorable safety profile.
Takeda executives emphasized that combating dengue requires more than vaccination alone. The company said it remains committed to working closely with governments and healthcare stakeholders across South and Southeast Asia to strengthen broader dengue prevention initiatives, including disease surveillance, public awareness campaigns, vector control programs, and community engagement.
“Dengue is a shared regional challenge that requires collaboration across borders and sectors,” said Peter Streibl, Cluster General Manager for Southeast Asia and India at Takeda.
“Our aim is to contribute to sustainable, evidence-based solutions that reflect the needs of each country.”
TAK-003 has gained significant international recognition in recent years. In 2023, the World Health Organization’s Strategic Advisory Group of Experts on Immunization endorsed the vaccine’s use without requiring pre-vaccination screening. The WHO subsequently recommended its use in dengue-endemic areas and granted it prequalification status, enabling procurement by international organizations to support wider vaccine access worldwide.
Beyond India, TAK-003 has already been approved in several countries across Asia, including Indonesia, Thailand, Malaysia, and Vietnam. Globally, the vaccine has been rolled out through both public and private immunization programs across Asia, Latin America, and Europe, including Brazil’s National Immunization Program and public vaccination initiatives in Argentina, Colombia, and Indonesia.
With dengue emerging as one of the world’s fastest-growing mosquito-borne diseases, India’s historic approval of TAK-003 represents a significant step toward expanding preventive tools for one of the populations most vulnerable to the disease.