&imwidth=800&imheight=600&format=webp&quality=medium "DCGI clears Takeda's QDENGA, India's first-ever dengue vaccine: Full details inside")
The Drug Controller General of India (DCGI) has approved Japanese company Takeda Biopharmaceuticals India’s dengue vaccine, QDENGA. It is the first such vaccine that India has greenlighted. The approved vaccine is designed to protect against all four dengue virus strains (DENV-1, DENV-2, DENV-3 and DENV-4) and can be administered despite prior dengue exposure. The company confirmed that the vaccine does not require pre-vaccination testing.
The vaccine is given as an under-the-skin (subcutaneous) injection, administered in a two-dose regimen of 0.5 mL each, which is spaced three months apart. While pricing has not been finalised yet, but are expected to be affordable for Indians, given that Takeda has partnered with Hyderabad-based Biological E to produce up to 50 million doses annually. The final price will also hinge on whether the vaccine is eventually included in government-run immunisation schemes.
The vaccine offers protection against all four strains of the dengue virus and is approved for people aged four to 60, irrespective of whether they've had dengue before, meaning no prior testing is required before vaccination. It stands out as the most rigorously researched dengue vaccine to date, with long-term data confirming lasting protection against both dengue infection and severe cases requiring hospitalisation.
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The clinical trial of QDENGA vaccine
Takeda's dengue vaccine QDENGA has been approved in India, backed by an extensive global clinical development programme spanning 19 Phase 1, 2, and 3 trials with over 28,000 participants across dengue-endemic and non-endemic regions. Central to this was the pivotal Phase III TIDES (DEN-301) trial involving more than 20,000 participants across eight countries.
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At 12 months post-second dose, the vaccine showed 80.2 per cent efficacy against virologically confirmed dengue, while at 18 months it demonstrated 90.4 per cent efficacy against dengue-related hospitalisation. Long-term data at 4.5 years showed 84.1 per cent efficacy in preventing hospitalisations, with safety and efficacy sustained for up to seven years across all four dengue serotypes.
The approval is further supported by DEN-302, a Phase III trial conducted specifically in Indian participants aged 4–60, which confirmed the vaccine's tolerability, safety, and immunogenicity across children, adolescents, and adults. Ongoing real-world evidence and pharmacovigilance continue to reinforce these findings.
WHO also gave a nod for the vaccine, confirming that it meets global standards for quality, safety and efficacy, and allowing eligibility for procurement using international agencies, including UNICEF and PAHO, to support broader access.
