New Delhi: The Drug Controller General of India (DCGI) has granted market authorisation to Takeda Biopharmaceuticals India’s QDENGA (TAK-003), making it the first dengue vaccine to be approved in the country, according to a press release issued by the company. Reported dengue cases in India rose 11-fold in the past two decades, according to Takeda Biopharmaceuticals India.
QDENGA, designed to protect against all four dengue virus serotypes, is indicated for the prevention of dengue in children and adults aged 4 to 60 years, the company said. The vaccine, approved in 43 countries so far, showed in a late-stage trial an efficacy of 80.2% against confirmed dengue cases one year after the second dose. It also showed 90.4% efficacy against dengue-related hospitalizations after 18 months, meeting the secondary end point of the study, according to the company. Takeda India had partnered with Indian vaccine maker Biological E in 2024 to expand the drug’s manufacturing.
QDENGA is administered as a two-dose, 0.5 ml injection given three months apart and can be used regardless of prior dengue exposure, eliminating the need for pre-vaccination testing. This differs from Sanofi’s Dengvaxia, which is not approved in India and is recommended only for people with prior dengue infection due to concerns about an increased risk of severe dengue in some without previous exposure to the virus, said Divya KS, an infectious diseases specialist at Apollo Hospitals. Regulators may have required additional post-marketing safety data before granting approval, according to Divya.
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