India has approved its first dengue vaccine after the Drug Controller General of India (DCGI) granted market authorisation to QDENGA (TAK-003), developed by Takeda Biopharmaceuticals India. The approval marks an important development in the country's efforts to strengthen dengue prevention, as the disease continues to affect millions of people every year.
QDENGA has been approved for individuals aged 4 to 60 years and can be administered regardless of whether a person has previously been infected with dengue. According to the company, the vaccine does not require pre-vaccination screening, allowing eligible individuals to receive it without first being tested for past dengue infection.
The approval comes as India continues to face a high dengue burden. According to Takeda, the country accounts for nearly one-third of the global dengue burden, with reported dengue cases increasing almost 11-fold over the past two decades.
QDENGA Becomes India's First Approved Dengue Vaccine
QDENGA is a live-attenuated tetravalent vaccine designed to provide protection against all four dengue virus serotypes.
The vaccine is given as a two-dose regimen, with 0.5 mL injections administered under the skin three months apart.
One of the key features highlighted by Takeda is that the vaccine can be given whether or not a person has had dengue before. Unlike some dengue vaccines, previous dengue testing is not required before vaccination.
According to the company, this allows eligible individuals to receive the vaccine without additional pre-vaccination screening.
Approval Supported by Global and Indian Clinical Studies
The DCGI's approval is based on Takeda's global clinical development programme, which included 19 Phase I, II and III clinical trials involving more than 28,000 participants from dengue-endemic and non-endemic regions.
The programme included the Phase III TIDES (DEN-301) trial, which enrolled more than 20,000 participants across eight dengue-endemic countries.
According to Takeda, the study demonstrated:
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80.2% efficacy against virologically confirmed dengue 12 months after the second dose.
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90.4% efficacy against dengue-related hospitalisation 18 months after vaccination.
The company also reported that follow-up data collected over 4.5 years showed 84.1% efficacy against dengue-related hospitalisation. In addition, seven-year follow-up data demonstrated continued protection against dengue disease and dengue-related hospitalisation across all four dengue virus serotypes.
The Indian approval was also supported by findings from the Phase III DEN-302 clinical trial, which evaluated the vaccine in participants between 4 and 60 years of age.
According to Takeda, the study found QDENGA to be safe, well tolerated and immunogenic in children, adolescents and adults.
Available in 43 Countries Since 2022
Although this is the first dengue vaccine approved in India, QDENGA has already been introduced in several countries around the world.
Takeda said the vaccine has been approved in 43 countries since its launch in 2022, with more than 32 million doses distributed globally through public and private immunisation programmes.
Commenting on the approval, Mahender Nayak, Head of Intercontinental Markets at Takeda, said the approval marks an important step in strengthening dengue prevention in India.
He added that the vaccine's approval in 43 countries and the distribution of more than 32 million doses globally reflect its growing use since its launch.
WHO Recommendation Supports Vaccine Use
According to Takeda, the World Health Organisation (WHO) recommends QDENGA for use in dengue-endemic regions with high transmission and supports its inclusion in public immunisation programmes without requiring pre-vaccination screening.
The vaccine has also received WHO prequalification, confirming that it meets international standards for quality, safety and effectiveness.
This status also makes QDENGA eligible for procurement by international organisations, including UNICEF and the Pan American Health Organization (PAHO).
India Continues to Face a High Dengue Burden
Takeda said dengue has been reported in more than 125 countries, with India remaining one of the countries most affected by the disease.
According to the company, all four dengue virus serotypes are circulating simultaneously in several parts of India. It also noted that rapid urbanisation, climate change and widespread mosquito breeding continue to increase the risk of dengue infection across the country.
The company said the approval of QDENGA represents another step in supporting dengue prevention efforts in India.
Goh Choo Beng, Medical Affairs Head for Takeda's Southeast Asia and India Cluster, said the vaccine is designed to protect against all four dengue virus serotypes regardless of previous exposure.
He added that the approval strengthens India's comprehensive dengue prevention strategy alongside vector control, surveillance, community awareness and other public health measures.
Next Steps Following Approval
Following the regulatory approval, Takeda said it will work with Indian regulatory authorities, healthcare providers and public health stakeholders to support the planning and availability of QDENGA in India.
The company said the approval represents an important milestone in expanding dengue prevention efforts and supporting public health initiatives across the country.
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Conclusion
The approval of QDENGA (TAK-003) marks an important milestone for dengue prevention in India. As the country's first approved dengue vaccine, it is authorised for people aged 4 to 60 years, does not require pre-vaccination screening and is designed to protect against all four dengue virus serotypes.
Supported by global and Indian clinical studies and already approved in 43 countries, the vaccine adds a new option to India's efforts to address its growing dengue burden. As Takeda works with health authorities to support its availability, the approval represents another important step in strengthening dengue prevention in the country.