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Rachel V Thomas

India’s First Approved Dengue Vaccine: Takeda’s QDENGA Protects Against All Four Virus Serotypes

<span>Takeda</span> Biopharmaceuticals India today announced that <span>QDENGA</span> (TAK-003) has become the first <span>dengue vaccine</span> to receive approval in India, marking a major milestone in the country's fight against the mosquito-borne disease.

The Drug Controller General of India (DCGI) has granted market authorization for QDENGA to prevent dengue in individuals aged 4-60 years. According to Takeda, it is India's first approved dengue vaccine and can be administered regardless of previous dengue infection, without requiring pre-vaccination testing.

"Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India," said Dr. Mahender Nayak, Head of Intercontinental Markets.

<h2>QDENGA Vaccine: Why The Approval Matters</h2>

The approval comes at a critical time as dengue cases in India have risen sharply over the past two decades.

India accounts for nearly one-third of the global dengue burden. In 2025, more than 113,000 dengue cases were officially reported, although modelling studies suggest the true number of infections may run into tens of millions annually due to underreporting.

Rapid urbanization, climate change and widespread mosquito breeding have made dengue a year-round public health concern. Since there is no specific antiviral treatment for dengue, prevention remains the most effective strategy.

"India carries a substantial dengue burden, and all four dengue virus serotypes co-circulate in several regions. QDENGA is designed to protect against all four serotypes regardless of prior exposure," said Dr. Goh Choo Beng, Medical Affairs Head, Southeast Asia &amp; India Cluster.

Also read: <a href="https://www.healthandme.com/health-news/dengue-serotypes-shifting-in-young-adults-how-indias-indigenous-vaccine-could-help-prevent-severe-disease-article-154627273" data-type="tilCustomLink">Dengue Serotypes Shifting In Young Adults: How India's Indigenous Vaccine Could Help Prevent Severe Disease</a>

The DCGI approval is supported by Takeda's global clinical development programme comprising 19 Phase 1, 2 and 3 clinical trials involving more than 28,000 participants in dengue-endemic and non-endemic regions.

The pivotal Phase III TIDES (DEN-301) study enrolled more than 20,000 participants across eight countries and evaluated the vaccine's long-term safety and effectiveness.

<ul><li>80.2% vaccine efficacy against virologically confirmed dengue one year after the second dose.</li><li>90.4% efficacy against dengue-related hospitalization at 18 months.</li><li>84.1% protection against dengue-related hospitalization after 4.5 years.</li><li>Safety and efficacy data demonstrating protection for up to seven years across all four dengue virus serotypes.</li></ul>

The approval is also supported by an Indian Phase III (DEN-302) trial involving participants aged 4-60 years, which found QDENGA to be safe, well-tolerated and immunogenic in children, adolescents and adults.

<strong>Read More: <a href="https://www.healthandme.com/health-wellness/dengue-is-spreading-beyond-monsoons-and-into-new-regions-across-india-says-expert-article-154332385" data-type="tilCustomLink">Dengue Is Spreading Beyond Monsoons And Into New Regions Across India, Says Expert</a> </strong><h2></h2>

QDENGA (TAK-003) is a live-attenuated tetravalent dengue vaccine designed to protect against all four dengue virus serotypes.

It is administered as two 0.5 mL subcutaneous doses, given three months apart.

The vaccine is built on a DENV-2 backbone, incorporating structural proteins from DENV-1, DENV-3 and DENV-4 to provide broad immune protection.

The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic settings without the need for pre-vaccination screening. The vaccine is also included in the WHO List of Prequalified Vaccines, allowing procurement through agencies such as UNICEF and PAHO.

The vaccine has been approved in 43 countries across Asia, Latin America and Europe. It is already part of Brazil's National Immunization Program and is available through public immunization programmes in Argentina, Colombia and Indonesia.

The vaccine is approved in India for people aged 4-60 years to help prevent dengue disease.

Takeda had partnered with Indian vaccine manufacturer Biological E in 2024 to expand production of QDENGA.

Under the agreement, Biological E plans to manufacture 50 million doses annually, supporting Takeda's goal of producing 100 million doses globally each year by the end of the decade.

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QDENGA

Dengue Vaccine

India First Approved Dengue Vaccine QDENGA

QDENGA  dengue vaccine

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Takeda Biopharmaceuticals India today announced that QDENGA (TAK-003) has become the first dengue vaccine to receive approval in India, marking a major milestone in the country's fight against the mosquito-borne disease.The Drug Controller General of India (DCGI) has granted market authorization for QDENGA to prevent dengue in individuals aged 4-60 years. According to Takeda, it is India's first approved dengue vaccine and can be administered regardless of previous dengue infection, without requiring pre-vaccination testing."Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India," said Dr. Mahender Nayak, Head of Intercontinental Markets.QDENGA Vaccine: Why The Approval MattersThe approval comes at a critical time as dengue cases in India have risen sharply over the past two decades.India accounts for nearly one-third of the global dengue burden. In 2025, more than 113,000 dengue cases were officially reported, although modelling studies suggest the true number of infections may run into tens of millions annually due to underreporting.Rapid urbanization, climate change and widespread mosquito breeding have made dengue a year-round public health concern. Since there is no specific antiviral treatment for dengue, prevention remains the most effective strategy."India carries a substantial dengue burden, and all four dengue virus serotypes co-circulate in several regions. QDENGA is designed to protect against all four serotypes regardless of prior exposure," said Dr. Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster.Also read: Dengue Serotypes Shifting In Young Adults: How India's Indigenous Vaccine Could Help Prevent Severe DiseaseQDENGA: Scientific Evidence The DCGI approval is supported by Takeda's global clinical development programme comprising 19 Phase 1, 2 and 3 clinical trials involving more than 28,000 participants in dengue-endemic and non-endemic regions.The pivotal Phase III TIDES (DEN-301) study enrolled more than 20,000 participants across eight countries and evaluated the vaccine's long-term safety and effectiveness.Key findings include:80.2% vaccine efficacy against virologically confirmed dengue one year after the second dose.90.4% efficacy against dengue-related hospitalization at 18 months.84.1% protection against dengue-related hospitalization after 4.5 years.Safety and efficacy data demonstrating protection for up to seven years across all four dengue virus serotypes.The approval is also supported by an Indian Phase III (DEN-302) trial involving participants aged 4-60 years, which found QDENGA to be safe, well-tolerated and immunogenic in children, adolescents and adults.Read More: Dengue Is Spreading Beyond Monsoons And Into New Regions Across India, Says Expert What Is QDENGA?QDENGA (TAK-003) is a live-attenuated tetravalent dengue vaccine designed to protect against all four dengue virus serotypes.It is administered as two 0.5 mL subcutaneous doses, given three months apart.The vaccine is built on a DENV-2 backbone, incorporating structural proteins from DENV-1, DENV-3 and DENV-4 to provide broad immune protection.The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic settings without the need for pre-vaccination screening. The vaccine is also included in the WHO List of Prequalified Vaccines, allowing procurement through agencies such as UNICEF and PAHO.The vaccine has been approved in 43 countries across Asia, Latin America and Europe. It is already part of Brazil's National Immunization Program and is available through public immunization programmes in Argentina, Colombia and Indonesia.Who can take QDENGA?The vaccine is approved in India for people aged 4-60 years to help prevent dengue disease.Manufacturing In IndiaTakeda had partnered with Indian vaccine manufacturer Biological E in 2024 to expand production of QDENGA.Under the agreement, Biological E plans to manufacture 50 million doses annually, supporting Takeda's goal of producing 100 million doses globally each year by the end of the decade.

india’s first approved dengue vaccine: takeda’s qdenga protects against all four virus serotypes

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