Takeda’s QDENGA approved in India, can be given despite pre-exposure to dengue

Takeda Biopharmaceuticals India has received market authorisation from the Indian drug regulatory authority for QDENGA, its dengue vaccine for prevention of the disease in the 4–60 years age group. It is the first dengue vaccine approved in India that can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing, the multinational healthcare company said.

Dengue is a mosquito-borne viral disease, and a global public health threat, with prevalence in over 125 countries. India accounts for nearly one-third of the global dengue burden, a note from the company said. In 2025, reported cases exceeded 113,000, but modelling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year, it added.

QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection across all four dengue virus serotypes. It is administered subcutaneously as a 0.5 mL as a two-dose regimen, with doses given three months apart. Recommended by the WHO for use in dengue-endemic settings, the vaccine had received WHO prequalification, a couple of years ago.

The approval in India is based on results from Takeda’s global clinical development program, involving 19 Phase 1, 2 and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions, the company said. This included the pivotal Phase III TIDES (DEN-301) trial, which evaluated the vaccine in over 20,000 participants across eight countries over an extended period to evaluate both the long-term safety and efficacy of QDENGA, it added.

The approval is also supported by data from a Phase III clinical trial (DEN-302) conducted in Indian participants, which evaluated the safety and immunogenicity of the vaccine in individuals aged 4–60 years, the company said. “The study demonstrated that QDENGA was found to be tolerated, safe and immunogenic in healthy adults, adolescents and children. These clinical outcomes are further supported by real-world evidence generation and ongoing pharmacovigilance to deepen understanding of the vaccine’s safety and impact,” it added.  

Mahender Nayak, Takeda’s Head of Intercontinental Markets said, “Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalisation across all four serotypes; an important milestone for communities and health systems.” Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally, he said.

Peter Streibl, General Manager, Southeast Asia and India Cluster added, “Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals, and partners across South and Southeast Asia, not only to support access to QDENGA, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control, and community engagement.”

Goh Choo Beng, Medical Affairs Head Southeast Asia and India Clustersaid, “India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. QDENGA is designed to protect against all four serotypes, regardless of prior exposure.”

QDENGA has been approved in 43 countries across Asia, Latin America and Europe, including India, with more than 32 million doses distributed globally through public and private programs, it said.

Published on July 20, 2026