Govt approves first dengue vaccine for ages 4-60 by Japanese drugmaker Takeda
Takeda's unit said on Monday that this approval makes QDENGA the first dengue vaccine to be approved in the country.
- Jul 20, 2026,
- Updated Jul 20, 2026 1:48 PM IST
India has approved its first dengue vaccine, with the Drug Controller General of India clearing Takeda Biopharmaceuticals India's QDENGA for the prevention of dengue in individuals aged 4 to 60 years under the New Drugs and Clinical Trials Rules, 2019.
Takeda's unit said on Monday that this approval makes QDENGA the first dengue vaccine to be approved in the country.
The company stated that the approval comes at a critical time for public health as reported dengue cases in India have risen eleven-fold over the past two decades. India accounts for nearly one-third of the global dengue burden. While reported cases crossed 113,000 in 2025, modelling analyses suggest the actual burden could be far higher, with tens of millions of infections each year.
QDENGA is a tetravalent, live-attenuated vaccine designed to protect against all four dengue virus serotypes. It can be given regardless of prior dengue exposure and does not require pre-vaccination testing. The vaccine is administered subcutaneously as a 0.5 mL two-dose regimen, with the doses given three months apart.
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The company added that dengue is difficult to manage because there is no specific treatment and it can quickly progress to severe complications requiring hospitalisation and intensive care.
QDENGA is recommended by the World Health Organization for use in dengue-endemic settings and supports introduction into public immunisation programmes in areas with high transmission without the need for pre-vaccination screening. The vaccine has also received WHO pre-qualification, confirming its quality, safety and efficacy, and making it eligible for procurement through international agencies such as UNICEF and PAHO.
Since its launch in 2022, QDENGA has been approved in 43 countries across Asia, Latin America and Europe, with more than 32 million doses distributed globally through public and private programmes.
The approval in India is based on Takeda's global clinical development programme covering 19 Phase 1, 2 and 3 trials involving more than 28,000 participants in endemic and non-endemic regions. This included the Phase III TIDES trial, or DEN-301, which studied more than 20,000 participants across eight countries over an extended period.
India has approved its first dengue vaccine, with the Drug Controller General of India clearing Takeda Biopharmaceuticals India's QDENGA for the prevention of dengue in individuals aged 4 to 60 years under the New Drugs and Clinical Trials Rules, 2019.
Takeda's unit said on Monday that this approval makes QDENGA the first dengue vaccine to be approved in the country.
The company stated that the approval comes at a critical time for public health as reported dengue cases in India have risen eleven-fold over the past two decades. India accounts for nearly one-third of the global dengue burden. While reported cases crossed 113,000 in 2025, modelling analyses suggest the actual burden could be far higher, with tens of millions of infections each year.
QDENGA is a tetravalent, live-attenuated vaccine designed to protect against all four dengue virus serotypes. It can be given regardless of prior dengue exposure and does not require pre-vaccination testing. The vaccine is administered subcutaneously as a 0.5 mL two-dose regimen, with the doses given three months apart.
MUST READ | UNICEF, Gavi seek vaccine makers as Ebola outbreak spurs push for Bundibugyo shots
The company added that dengue is difficult to manage because there is no specific treatment and it can quickly progress to severe complications requiring hospitalisation and intensive care.
QDENGA is recommended by the World Health Organization for use in dengue-endemic settings and supports introduction into public immunisation programmes in areas with high transmission without the need for pre-vaccination screening. The vaccine has also received WHO pre-qualification, confirming its quality, safety and efficacy, and making it eligible for procurement through international agencies such as UNICEF and PAHO.
Since its launch in 2022, QDENGA has been approved in 43 countries across Asia, Latin America and Europe, with more than 32 million doses distributed globally through public and private programmes.
The approval in India is based on Takeda's global clinical development programme covering 19 Phase 1, 2 and 3 trials involving more than 28,000 participants in endemic and non-endemic regions. This included the Phase III TIDES trial, or DEN-301, which studied more than 20,000 participants across eight countries over an extended period.