DCGI grants advertising and marketing authorisation to Takeda’s TAK-003 for people aged 4 to 60, no matter prior dengue publicity and with out pre-vaccination testing.
- The approval comes at a essential time for public well being, as reported dengue circumstances in India have elevated 11-fold prior to now 20 years[1]
- Takeda’s dengue vaccine (TAK-003) is essentially the most extensively studied dengue vaccine, with long-term information demonstrating sustained safety in opposition to dengue illness and dengue-related hospitalization
Takeda introduced that India’s Drug Controller Common of India (DCGI) has granted advertising and marketing authorization for Takeda’s dengue vaccine (TAK-003) for the prevention of dengue illness in people 4 (4) to 60 (sixty) years of age. TAK-003 is India’s first-ever authorised dengue vaccine and was authorised to be used in people no matter earlier dengue publicity, with out the necessity for pre-vaccination testing.
Like many international locations in South and Southeast Asia, dengue transmission in India is not confined to monsoon season. A number of states report sustained year-round dengue transmissions increasing throughout each city and rural areas. Reported circumstances exceeded 233,000 in 2024, however modeling analyses recommend the dengue burden in India seems to be increased than reported, probably representing tens of hundreds of thousands of infections annually. With circumstances rising greater than 11-fold prior to now 20 years and outbreaks rising extra frequent and more durable to foretell, dengue is not a sporadic public well being risk – it is an accelerating world problem.
“Dengue is a rising public well being problem, and India wants sustained, evidence-based prevention. The newest seven-year information for TAK-003 exhibits continued safety in opposition to dengue an infection and hospitalization throughout all 4 serotypes; an necessary milestone for communities and well being methods. Since its launch in 2022, TAK-003 has been authorised in 43 international locations, with greater than 32 million doses distributed globally. This approval marks an necessary step ahead in strengthening dengue prevention in India. Constructing on Takeda’s 245-year heritage and greater than 70 years of vaccine experience, we stay dedicated to working with public well being authorities, healthcare professionals, and companions to help equitable and sustainable entry,” stated Dr. Mahender Nayak, Head of Intercontinental Markets, Takeda.
TAK-003’s approval in India is supported by an intensive world scientific improvement program, together with an area Part 3 examine in addition to information from the pivotal Part 3 Tetravalent Immunization in opposition to Dengue Efficacy Research (TIDES), the most important and longest efficacy trial performed for a dengue vaccine. Within the TIDES trial, TAK-003 demonstrated sustained safety in opposition to dengue and dengue‑associated hospitalization and a good security profile.
“Dengue is a shared regional problem that requires collaboration throughout borders and sectors. Takeda is dedicated to working with governments, public well being authorities, healthcare professionals and companions throughout South and Southeast Asia, not solely to help entry to TAK-003, the place authorised and beneficial, but in addition to strengthen broader dengue prevention efforts, together with surveillance, consciousness, vector management and neighborhood engagement. Our intention is to contribute to sustainable, evidence-based options that mirror the wants of every nation,” stated Peter Streibl, Cluster Common Supervisor, Southeast Asia and India, Takeda.
Since 2023, WHO’s Strategic Advisory Group of Specialists on Immunization (SAGE) endorsed using TAK-003 with out the necessity for pre-vaccination screening.[4] Since then, TAK-003 has been beneficial by the WHO to be used in dengue-endemic settings, supporting its introduction in public immunization applications in areas with excessive transmission.[4] The vaccine has additionally obtained WHO prequalification, confirming it meets world requirements for high quality, security and efficacy, and enabling eligibility for procurement by means of worldwide companies resembling UNICEF and PAHO to help wider entry.[5]
Following the approval by DCGI, Takeda will proceed to collaborate with Indian regulatory authorities, public well being stakeholders, and healthcare suppliers to help the planning, supply, and availability, of TAK-003 in India.
Along with India, TAK-003 can also be authorised in Indonesia, Thailand, Malaysia and Vietnam throughout the area. Up to now, TAK-003 has been distributed worldwide by means of private and non-private applications throughout Asia, Latin America and Europe, together with Brazil’s Nationwide Immunization Program and public applications in Argentina, Colombia and Indonesia.
