India’s drug regulator has approved Takeda Pharmaceutical’s dengue vaccine Qdenga, making it the first dengue vaccine to receive regulatory clearance in the country, the Japanese pharmaceutical company’s India unit announced on Monday.
Takeda has partnered with Hyderabad-based vaccine manufacturer Biological E to produce Qdenga (TAK-003) in India. The two-dose vaccine is designed to protect children and adults aged 4 to 60 years against all four dengue virus serotypes.
The vaccine is expected to become available in India’s private healthcare sector in the first half of 2027 following market authorization.
Under the manufacturing partnership, the companies aim to produce up to 50 million doses annually to meet potential demand.
Dengue is a mosquito-borne viral disease and one of the world’s fastest-growing vector-borne illnesses. According to the World Health Organization, global dengue cases reached a record 14.4 million in 2024, with 11,201 deaths reported. India recorded 232,425 cases and 233 deaths during the same period.
Takeda said clinical trials showed Qdenga provided 80.2% protection against confirmed dengue infections one year after the second dose and demonstrated 90.4% effectiveness in preventing dengue-related hospitalizations after 18 months.
