July 20 (Reuters) – Japan’s Takeda Pharmaceutical’s dengue vaccine QDENGA has been approved by India’s drug regulator, making it the first dengue vaccine to be approved in the country, the company’s unit said on Monday.
The tetravalent live-attenuated vaccine, designed to protect against all four dengue virus serotypes, can be administered regardless of prior dengue exposure and does not require pre-vaccination testing, the company said.
“The approval comes at a critical time for public health, as reported dengue cases in India have increased 11-fold in the past two decades,” the company said.
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 hospitalization, Takeda said.
(Reporting by Rishika Sadam; Editing by Janane Venkatraman and Nivedita Bhattacharjee)
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