Takeda Biopharmaceuticals India has received regulatory approval to market its dengue vaccine QDENGA – making it the first to get a go-ahead in the country.
The dengue vaccine landscape in India has Panacea Biotec and Indian Immunologicals Ltd developing candidates.
India accounts for nearly one-third of the global dengue burden, a note from Takeda said.
Mahender Nayak, Takeda’s Head of Intercontinental Markets said, “Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention.
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.
Takeda Biopharmaceuticals India has received regulatory approval to market its dengue vaccine QDENGA – making it the first to get a go-ahead in the country.
A key feature of the vaccine is that it can be given to an individual despite previous exposure to dengue, and without pre-vaccination testing, the company said, adding that it is approved in the 4 -60 years age group. The Japanese drugmaker Takeda had partnered with India’s Biological E, about two years ago, to bolster local and global supplies. Multidose vials would be made for government procurement in endemic countries by 2030, to support national immunisation programmes, a global announcement by the two companies, had then said.
While the company has received a marketing authorisation for India, the vaccine is likely to be available locally only in the first half of 2027, as several other regulatory steps involving imports and so on, need to be completed, said Peter Streibl, Takeda General Manager, Southeast Asia and India Cluster, in an emailed response. The vaccine will be imported from Germany, and “pricing and availability will be communicated once local processes are complete,” Streibl told businessline.
QDENGA is a live-attenuated vaccine that protects against four dengue virus serotypes. It is administered subcutaneously 0.5 mL as a two-dose regimen, given three months apart, the company said. It has been recommended by the WHO for use in dengue-endemic settings, and has received WHO prequalification – allowing for easy adoption in low-resource countries. The dengue vaccine landscape in India has Panacea Biotec and Indian Immunologicals Ltd developing candidates. Globally through, Sanofi was also in the fray, but has stopped production in certain markets due to low demand, an industry-insider 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 Takeda 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.
The India approval 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 hospitalization 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.
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.
(eom)
Published on July 20, 2026
