DCGI grants advertising 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 twenty years[1]
- Takeda’s dengue vaccine (TAK-003) is essentially the most extensively studied dengue vaccine, with long-term information demonstrating sustained safety towards dengue illness and dengue-related hospitalization
Takeda introduced that India’s Drug Controller Common of India (DCGI) has granted advertising 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 now 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 counsel the dengue burden in India seems to be greater than reported, possible representing tens of thousands and thousands of infections annually. With circumstances rising greater than 11-fold prior to now twenty years and outbreaks rising extra frequent and tougher to foretell, dengue is now not a sporadic public well being menace – it is an accelerating international 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 towards dengue an infection and hospitalization throughout all 4 serotypes; an necessary milestone for communities and well being techniques. 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 assist equitable and sustainable entry,” mentioned Dr. Mahender Nayak, Head of Intercontinental Markets, Takeda.
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TAK-003’s approval in India is supported by an in depth international medical improvement program, together with a neighborhood Section 3 examine in addition to information from the pivotal Section 3 Tetravalent Immunization towards Dengue Efficacy Examine (TIDES), the most important and longest efficacy trial performed for a dengue vaccine. Within the TIDES trial, TAK-003 demonstrated sustained safety towards 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 assist entry to TAK-003, the place authorised and really useful, but additionally to strengthen broader dengue prevention efforts, together with surveillance, consciousness, vector management and neighborhood engagement. Our purpose is to contribute to sustainable, evidence-based options that replicate the wants of every nation,” mentioned Peter Streibl, Cluster Common Supervisor, Southeast Asia and India, Takeda.
Since 2023, WHO’s Strategic Advisory Group of Specialists on Immunization (SAGE) endorsed the usage of TAK-003 with out the necessity for pre-vaccination screening.[4]Â Since then, TAK-003 has been really useful by the WHO to be used in dengue-endemic settings, supporting its introduction in public immunization packages in areas with excessive transmission.[4]Â The vaccine has additionally acquired WHO prequalification, confirming it meets international requirements for high quality, security and efficacy, and enabling eligibility for procurement via worldwide companies corresponding to UNICEF and PAHO to assist 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 assist the planning, supply, and availability, of TAK-003 in India.
Along with India, TAK-003 can be authorised in Indonesia, Thailand, Malaysia and Vietnam throughout the area. Up to now, TAK-003 has been distributed worldwide via private and non-private packages throughout Asia, Latin America and Europe, together with Brazil’s Nationwide Immunization Program and public packages in Argentina, Colombia and Indonesia.
