Japanese drug maker Takeda’s QDENGA has become the first dengue vaccine to be approved in India.
The Drug Controller General of India has cleared the vaccine for the prevention of dengue in individuals aged 4 to 60 years.
Takeda Pharmaceuticals said that the vaccine can be administered regardless of whether a person has been previously infected with dengue.
It also does not require pre-vaccination testing, making it easier to deploy.
The company said that the approval comes at a critical time for public health as dengue cases in India have risen, accounting for nearly one-third of global dengue infections.
In 2025, reported cases crossed 113,000. Modelling analyses suggested that the actual number could be higher.
QDENGA is a tetravalent live-attenuated vaccine. It is designed to protect against all four dengue virus serotypes.
Mahender Nayak, Head of Intercontinental Markets at Takeda, said that QDENGA has been approved in 43 countries since its launch in 2022, with more than 32 million doses distributed globally.
The vaccine is administered under the skin as two doses three months apart.
The approval for the vaccine is based on findings from Takeda’s global clinical development programme, which included 19 phase I, II, and III clinical trials involving about 28,000 participants.
After a 4.5-year follow-up, the testing showed that the vaccine demonstrated 84 per cent protection against dengue-related hospitalisation and around 61 per cent protection against virologically confirmed dengue overall.
Takeda partnered with Indian vaccine maker Biological E in 2024 to expand manufacturing of QDENGA.
Under the agreement, Biological E plans to build capacity to produce 50 million doses annually, supporting Takeda's goal of manufacturing 100 million doses a year globally by the end of the decade.
Dengue is a mosquito-borne viral disease that poses a significant global public health threat, and India accounts for nearly one-third of the global dengue burden, the company said.
"Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally," said Mahender Nayak, head of Intercontinental markets.
The vaccine's long-term data demonstrated sustained protection against dengue disease and dengue-related hospitalisation, Takeda said.
