If you’ve ever battled mosquitoes as though your health depended on it because sometimes it truly does there’s finally a promising development. Japanese pharmaceutical company Takeda is preparing to introduce its dengue vaccine, TAK-003, in India by 2026 through a manufacturing partnership with Hyderabad-based Biological E (Bio E). The initiative aligns with the Indian government’s Make-in-India vision.
Takeda confirmed that its regulatory submission is under review, and the vaccine will be launched once all necessary approvals from Indian authorities are secured.
Global Approvals and Effectiveness
TAK-003 received WHO prequalification in May 2024 and has already been approved in 40 countries, including Brazil, Argentina, Thailand, Indonesia, and EU nations. Since its global launch in 2023, over 10 million doses have been distributed. Although India hasn’t approved it yet, the Central Drugs Standard Control Organisation (CDSCO) recently gave clearance for local clinical trials.
Notably, TAK-003 is the second dengue vaccine to receive WHO prequalification, after Sanofi’s Dengvaxia. Unlike Dengvaxia which is recommended only for individuals with a prior confirmed dengue infection TAK-003 can be given regardless of previous exposure, making it more suitable for broad use in dengue-endemic regions.
How TAK-003 Works
TAK-003 is a tetravalent live-attenuated vaccine, designed to offer protection against all four dengue virus strains (DENV-1, DENV-2, DENV-3, and DENV-4). It contains weakened versions of the viruses, which cannot cause illness but are effective in triggering the immune system to build long-lasting immunity.
Who Can Receive the Vaccine?
The World Health Organization recommends TAK-003 for children aged 6 to 16 years in regions with high rates of dengue. It is not advised for children under six due to reduced effectiveness. People with underlying health conditions may also be eligible in endemic areas, provided there’s strong evidence of severe dengue risks in those populations. WHO currently sets an age range of 6 to 60 years for individuals with comorbidities.
Who Should Avoid the Vaccine?
WHO has outlined safety exclusions. The vaccine should not be given to:
- Pregnant women or those planning pregnancy within a month after vaccination
- Breastfeeding women
- Individuals with immune deficiencies or undergoing immunosuppressive treatments
- People with symptomatic or immunocompromised HIV infection
Dosage and Duration
TAK-003 is administered in two doses, spaced three months apart. No boosters are recommended at this time. Clinical trials show protection lasting up to 4.5 years, with ongoing studies evaluating long-term durability. The vaccine is injected into the deltoid region of the upper arm.
Efficacy and Safety
A February 2024 study in The Lancet Global Health revealed that TAK-003 is 64.2% effective in people with prior dengue exposure and 53.5% effective in those without. It was 84.1% effective in preventing hospitalisations. Takeda reports a consistent safety profile across age groups and exposure history.
India Rollout: Pricing and Access
As of April 2025, TAK-003 is not yet approved in India. Local trials are in progress, and Takeda plans to start distribution in 2026, pending regulatory greenlights. Biological E will produce up to 50 million doses annually, helping ensure sufficient supply.
Takeda intends to implement a dual pricing model offering different prices for public health systems and the private market. While Indian prices haven’t been announced, in other countries, a single dose costs between $40 and $115.
Public Immunisation Strategy
Takeda’s president of vaccines, Derek Wallace, confirmed that they aim to make the vaccine available through both public immunisation programmes and private healthcare providers. The initial public rollout will likely focus on children, in line with WHO guidance. In the private sector, both children and adults may be eligible.
Takeda’s collaboration with Bio E not only supports local production but also enhances global supply capacity. By the end of the decade, they aim to produce 100 million doses annually, with Bio E supplying half. While Takeda’s German facility only makes single-dose vials, Bio E will manufacture both single- and multi-dose formats, the latter being preferred for large-scale immunisation due to cost-effectiveness and storage efficiency.
A Critical Tool—But Not a Complete Solution
Despite its promise, WHO emphasizes that TAK-003 is not a standalone solution. Vaccination should be part of a broader dengue control strategy that includes mosquito control, community education, and proper case management.
Why This Matters for India
Dengue has become a major public health concern in India. In 2024 alone, the country reported over 230,000 cases and 236 deaths, according to the Ministry of Health’s National Center for Vector Borne Diseases Control. The upcoming availability of TAK-003 could mark a turning point in the fight against this growing epidemic.
India to Launch First Dengue Vaccine TAK-003 by 2026
If you’ve ever battled mosquitoes as though your health depended on it because sometimes it truly does there’s finally a promising development. Japanese pharmaceutical company Takeda is preparing to introduce its dengue vaccine, TAK-003, in India by 2026 through a manufacturing partnership with Hyderabad-based Biological E (Bio E). The initiative aligns with the Indian government’s Make-in-India vision.
Takeda confirmed that its regulatory submission is under review, and the vaccine will be launched once all necessary approvals from Indian authorities are secured.
Global Approvals and Effectiveness
TAK-003 received WHO prequalification in May 2024 and has already been approved in 40 countries, including Brazil, Argentina, Thailand, Indonesia, and EU nations. Since its global launch in 2023, over 10 million doses have been distributed. Although India hasn’t approved it yet, the Central Drugs Standard Control Organisation (CDSCO) recently gave clearance for local clinical trials.
Notably, TAK-003 is the second dengue vaccine to receive WHO prequalification, after Sanofi’s Dengvaxia. Unlike Dengvaxia which is recommended only for individuals with a prior confirmed dengue infection—TAK-003 can be given regardless of previous exposure, making it more suitable for broad use in dengue-endemic regions.
How TAK-003 Works
TAK-003 is a tetravalent live-attenuated vaccine, designed to offer protection against all four dengue virus strains (DENV-1, DENV-2, DENV-3, and DENV-4). It contains weakened versions of the viruses, which cannot cause illness but are effective in triggering the immune system to build long-lasting immunity.
Who Can Receive the Vaccine?
The World Health Organization recommends TAK-003 for children aged 6 to 16 years in regions with high rates of dengue. It is not advised for children under six due to reduced effectiveness. People with underlying health conditions may also be eligible in endemic areas, provided there’s strong evidence of severe dengue risks in those populations. WHO currently sets an age range of 6 to 60 years for individuals with comorbidities.
Who Should Avoid the Vaccine?
WHO has outlined safety exclusions. The vaccine should not be given to:
- Pregnant women or those planning pregnancy within a month after vaccination
- Breastfeeding women
- Individuals with immune deficiencies or undergoing immunosuppressive treatments
- People with symptomatic or immunocompromised HIV infection
Dosage and Duration
TAK-003 is administered in two doses, spaced three months apart. No boosters are recommended at this time. Clinical trials show protection lasting up to 4.5 years, with ongoing studies evaluating long-term durability. The vaccine is injected into the deltoid region of the upper arm.
Efficacy and Safety
A February 2024 study in The Lancet Global Health revealed that TAK-003 is 64.2% effective in people with prior dengue exposure and 53.5% effective in those without. It was 84.1% effective in preventing hospitalisations. Takeda reports a consistent safety profile across age groups and exposure history.
India Rollout: Pricing and Access
As of April 2025, TAK-003 is not yet approved in India. Local trials are in progress, and Takeda plans to start distribution in 2026, pending regulatory greenlights. Biological E will produce up to 50 million doses annually, helping ensure sufficient supply.
Takeda intends to implement a dual pricing model offering different prices for public health systems and the private market. While Indian prices haven’t been announced, in other countries, a single dose costs between $40 and $115.
Public Immunisation Strategy
Takeda’s president of vaccines, Derek Wallace, confirmed that they aim to make the vaccine available through both public immunisation programmes and private healthcare providers. The initial public rollout will likely focus on children, in line with WHO guidance. In the private sector, both children and adults may be eligible.
Takeda’s collaboration with Bio E not only supports local production but also enhances global supply capacity. By the end of the decade, they aim to produce 100 million doses annually, with Bio E supplying half. While Takeda’s German facility only makes single-dose vials, Bio E will manufacture both single- and multi-dose formats, the latter being preferred for large-scale immunisation due to cost-effectiveness and storage efficiency.
A Critical Tool—But Not a Complete Solution
Despite its promise, WHO emphasizes that TAK-003 is not a standalone solution. Vaccination should be part of a broader dengue control strategy that includes mosquito control, community education, and proper case management.
Why This Matters for India
Dengue has become a major public health concern in India. In 2024 alone, the country reported over 230,000 cases and 236 deaths, according to the Ministry of Health’s National Center for Vector Borne Diseases Control. The upcoming availability of TAK-003 could mark a turning point in the fight against this growing epidemic.
