New Delhi: The Drug Controller General of India granted market authorisation on Monday for QDENGA, a live-attenuated dengue vaccine developed by Takeda Biopharmaceuticals India Pvt Ltd. The approval, issued under the New Drugs and Clinical Trials Rules of 2019, permits the administration of the vaccine to individuals aged between 4 and 60 years. Notably, QDENGA stands as the first dengue vaccine to secure regulatory approval in India. The formulation can be administered to individuals regardless of their previous exposure to the virus, completely eliminating the prerequisite for pre-vaccination screening or testing.
The regulatory nod comes at a crucial time for India, which shoulders nearly one-third of the global dengue burden. Widespread endemicity, rapid urbanization, and climate-related shifts have transformed the mosquito-borne viral disease into a year-round public health threat, causing substantial strain on hospital networks during seasonal surges. Takeda’s leadership emphasized that the vaccine is explicitly designed to protect against all four co-circulating dengue virus serotypes. Administered subcutaneously in a two-dose regimen spaced three months apart, the vaccine aims to mitigate severe, life-threatening clinical complications that lack specific antiviral treatments.
The DCGI approval is backed by an extensive global clinical development program involving over 28,000 participants across 19 individual trials, alongside a localized Phase III trial in India that confirmed the vaccine’s safety, tolerability, and immunogenicity across all target age groups. Long-term data from the pivotal global TIDES study revealed an overall vaccine efficacy of 80.2 per cent against virologically confirmed dengue at 12 months post-vaccination, and a 90.4 per cent efficacy against dengue-related hospitalizations at 18 months. Extended observations spanning 4.5 years demonstrated a sustained 84.1 per cent efficacy in preventing hospitalizations, with safety profiles remaining consistent for up to seven years.
QDENGA has already secured World Health Organization prequalification and is recommended for deployment in highly endemic regions without pre-vaccination screening, qualifying it for international procurement via agencies like UNICEF. Since its initial international launch in 2022, the vaccine has been approved in 43 countries across Europe, Latin America, and Asia, with over 32 million doses distributed globally. Following the Indian regulatory clearance, Takeda officials confirmed they will closely collaborate with national public health stakeholders, regulatory bodies, and healthcare providers to plan the sustainable rollout and delivery of the vaccine across the country.
