Takeda Pharmaceutical (4502.T) of Japan has received approval from India’s drug regulator for its dengue vaccine QDENGA, marking the first dengue vaccine to be authorised in the country, the company’s Indian sub-unit said on Monday.
Dengue is a mosquito-borne viral infection and ranks among the most rapidly spreading vector-borne diseases worldwide. In 2024, the World Health Organization documented a record 14.4 million dengue cases and 11,201 deaths globally, including 232,425 cases and 233 fatalities in India.
Takeda Biopharmaceuticals India has reported that dengue cases in India have increased elevenfold over the past twenty years.
The company’s vaccine, QDENGA, developed to protect against all four dengue virus serotypes, is indicated for the prevention of dengue in children and adults between 4 and 60 years of age.
The vaccine, which has so far been approved in 43 countries, demonstrated an efficacy of 80.2% against confirmed dengue cases one year after the second dose in a late-stage clinical trial.
It also showed 90.4% efficacy in preventing dengue-related hospitalizations after 18 months, thereby achieving the study’s secondary endpoint, according to the company.
In 2024, Takeda India entered into a partnership with Indian vaccine manufacturer Biological E to scale up production of the drug.
QDENGA is given as a two-dose 0.5 ml injection, with the doses spaced three months apart, and may be administered regardless of previous dengue infection, removing the requirement for pre-vaccination testing.
Unlike, unapproved drug in India Sanofi's Dengvaxia which is recommended only for people with prior dengue infection, QDENGA can be administered to the patients without prior dengue infection.