Takeda’s two-dose QDENGA vaccine, approved by the Drug Controller General of India, can be administered without prior dengue screening and is designed to protect against all four dengue virus serotypes
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.
The vaccine has been approved for the prevention of dengue disease in individuals aged 4 to 60 years. QDENGA is a live-attenuated tetravalent vaccine designed to provide protection against all four dengue virus serotypes and is administered as a two-dose regimen, with doses given three months apart, reports The Hindu.
According to the company, the vaccine can be administered irrespective of whether an individual has had a previous dengue infection and does not require pre-vaccination screening. The approval comes as dengue continues to pose a significant public health challenge in India, where reported cases have increased nearly 11-fold over the past two decades. India accounts for nearly one-third of the global dengue burden, although modelling studies suggest the actual number of infections is substantially higher than reported.
The approval is based on Takeda’s global clinical development programme comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants in dengue-endemic and non-endemic regions.
The company’s pivotal Phase III TIDES (DEN-301) trial enrolled more than 20,000 participants across eight dengue-endemic countries. According to Takeda, the vaccine demonstrated an efficacy of 80.2% against virologically confirmed dengue 12 months after the second dose and 90.4% efficacy against dengue-related hospitalisation at 18 months. Follow-up data at 4.5 years showed 84.1% efficacy against dengue-related hospitalisation, while seven-year follow-up demonstrated sustained protection against dengue disease and dengue-related hospitalisation across all four serotypes.
The approval in India was also supported by a Phase III clinical trial conducted among participants aged 4 to 60 years. The company said the study found the vaccine to be safe, well tolerated and immunogenic in children, adolescents and adults.
Takeda said QDENGA has been approved in 43 countries across Asia, Latin America and Europe, with more than 32 million doses distributed through public and private immunisation programmes. The vaccine is recommended by the World Health Organization for use in dengue-endemic settings with high transmission and has also received WHO prequalification. It is currently included in Brazil’s National Immunization Program and is available through public programmes in Argentina, Colombia and Indonesia.
The company said it would work with Indian regulatory authorities, public health stakeholders and healthcare providers to support the planning and availability of the vaccine in India.
