Takeda Biopharmaceuticals India Pvt. Ltd. has received market authorization from the Drug Controller General of India (DCGI) for QDENGA, making it the first dengue vaccine approved in India for the prevention of dengue in individuals aged 4–60 years. The vaccine can be administered without prior dengue screening, regardless of previous dengue infection, and is designed to protect against all four dengue virus serotypes.
The approval comes at a time when dengue continues to pose a significant public health challenge in India, which accounts for nearly one-third of the global disease burden. Reported dengue cases in the country have increased sharply over the past two decades, driven by rapid urbanisation, changing climatic conditions and the widespread presence of the disease.
Commenting on the approval, Dr. Mahender Nayak, Head – Intercontinental Markets, Takeda, said, “Dengue remains a growing public health concern, and India needs sustainable, evidence-based prevention strategies. QDENGA has demonstrated long-term protection against dengue infection and dengue-related hospitalisation across all four serotypes. This approval is an important milestone in strengthening dengue prevention efforts in India, and we remain committed to working with public health authorities and healthcare professionals to improve access to vaccination.”
Peter Streibl, General Manager, Southeast Asia and India Cluster, Takeda, said, “Dengue is a regional health challenge that requires collaboration across governments, healthcare providers and communities. Alongside improving access to QDENGA, we will continue supporting broader dengue prevention initiatives, including surveillance, awareness, vector control and community engagement.”
The approval is supported by Takeda’s global clinical development programme involving more than 28,000 participants across Phase I, II and III trials, including the pivotal TIDES study. Long-term data have demonstrated sustained protection against dengue disease and dengue-related hospitalisation for up to seven years. A Phase III study conducted in India also confirmed the vaccine to be safe, well tolerated and immunogenic in children, adolescents and adults.
Approved in 43 countries with more than 32 million doses distributed globally, QDENGA is recommended by the World Health Organization for use in dengue-endemic settings without the need for pre-vaccination testing. Following the DCGI approval, Takeda will work with healthcare authorities and stakeholders to support the vaccine’s rollout in India.
