India's first dengue vaccine TAK-003 to launch in 2026: Check details here

TAK-003, India's first dengue vaccine, expected to launch in 2026 after local trials; WHO-approved jab offers two-dose protection against all four dengue strains

If you have ever found yourself waging war against mosquitoes like your life depended on it (because sometimes, it really does), here’s some hopeful news: help may finally be on the way. Japanese drugmaker Takeda is gearing up to launch its dengue vaccine, TAK-003, in India by next year through a manufacturing partnership with Hyderabad-based Biological E (Bio E), in line with the ‘Make-in-India’ initiative.   "Our regulatory application is currently under review, and we will launch in India upon receipt of all requisite approvals from the regulatory authorities," said the company in a statement. 

Which countries have approved TAK-003 and how effective is it?

TAK-003 received prequalification from the World Health Organization (WHO) in May 2024. It has already been approved for use in 40 countries including Indonesia, Thailand, Argentina, Brazil, and members of the European Union (EU). Since its launch in 2023, over 10 million doses have been sold.

 

 

Takeda was recently given the green light to conduct trials of TAK-003 in India by the Central Drugs Standard Control Organisation (CDSCO). It has not been approved for use in India yet.

 

Takeda’s dengue vaccine is the second dengue vaccine to receive WHO prequalification, following Sanofi’s Dengvaxia. Unlike Dengvaxia, which is recommended only for individuals (aged 6 to 45 years) with confirmed prior dengue infection due to safety concerns, TAK-003 is approved for use regardless of prior dengue exposure, offering broader applicability in endemic regions. 

How does the TAK-003 dengue vaccine work against all four strains?

TAK-003 is a tetravalent live-attenuated vaccine designed to protect against all four dengue serotypes (DENV-1, DENV-2, DENV-3, and DENV-4).

 

It contains weakened (attenuated) forms of the virus that are still alive but have been modified so they do not cause disease in healthy individuals. These weakened viruses stimulate the immune system to produce a strong and lasting immune response. It mimics a natural infection closely enough to train the immune system effectively, offering broad protection against all major strains of the virus.

Who can get the TAK-003 dengue vaccine? WHO age and eligibility guidelines

The WHO recommends the use of TAK-003 in children aged 6 to 16 years in areas with high dengue transmission. It is not currently recommended for children under 6 years of age due to lower efficacy observed in this group.

 

According to WHO, people with comorbidities residing in dengue-endemic countries may be considered for vaccination even if they fall outside the recommended programme age range of 6 to 16 years, provided there is documented evidence of a significant burden of severe dengue outcomes within these subpopulations. However, until additional data on the efficacy and safety profile become available, WHO recommends a lower age limit of 6 years and an upper limit of 60 years for vaccinating people with comorbidities. 

Who should not take TAK-003 dengue vaccine: WHO issues safety exclusions

According to WHO, the TAK-003 vaccine should not be administered to:

 

• Women who are pregnant or planning to become pregnant at least one month following vaccination
• Women who are breastfeeding 
• People with congenital or acquired immune deficiency, including those receiving immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (for example 20 mg/day or 2 mg/kg body weight/day of prednisone for two weeks or more) within four weeks prior to vaccination 
• People with symptomatic Human Immunodeficiency Virus (HIV) infection or with asymptomatic HIV infection associated with evidence of impaired immune function 

Dengue vaccine dosage: How TAK-003 is administered and how long it lasts

TAK-003 is administered in a two-dose regimen spaced three months apart. According to WHO, currently, no annual or booster doses are recommended. Long-term studies have demonstrated sustained protection for up to 4.5 years, and ongoing research is evaluating the potential need for booster doses in the future.

 

The vaccine is typically injected into the upper arm’s deltoid region. It must not be administered intravascularly, intradermally, or intramuscularly. 

What do clinical trials say about TAK-003's efficacy and safety?

According to a February 2024 paper titled Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial, published in The Lancet Global Health, clinical trials have demonstrated that TAK-003 is efficacious in preventing symptomatic dengue infections. Over a follow-up period of 4.5 years, the vaccine showed an overall efficacy of 64.2 per cent in individuals with prior dengue exposure and 53.5 per cent in those without prior exposure. Efficacy against hospitalised dengue cases was reported at 84.1 per cent.

 

The company says the vaccine has been well tolerated, with a safety profile consistent across various age groups and baseline serostatus.

India dengue vaccine rollout: Pricing, manufacturing and availability

In India, as of April 2025, TAK-003 has not been approved for market use. Takeda has initiated local clinical trials in collaboration with Biological E to scale up production. The vaccine is expected to be available in Indian markets by 2026, pending regulatory approvals. “Biological E Limited (BE) to manufacture up to 50 million doses of TAK-003 per year,” the company said in a statement.

 

Takeda plans to implement a dual pricing strategy in India, with different pricing for public and private markets. Specific price points have not been disclosed.

 

In other countries, the maximum retail price of one dose of the vaccine ranges between $40 and $115.  

Will TAK-003 be included in India’s public vaccination programme?

Providing an update on the regulatory process, Derek Wallace, president of the global vaccine business unit at Takeda, said it was “ongoing and on track”, with clinical trials currently being conducted to generate local safety data. 

 

“We intend to introduce the vaccine simultaneously in both the private and public sectors. Like in many other countries, India’s National Immunisation Program is largely focused on the paediatric population. The initial discussions are aligned with WHO guidelines for implementing public programmes for children. However, in the private sector, we will offer the vaccine to both paediatric and adult populations,” Wallace added.

 

He further said, “Given that dengue threatens half the world’s population, ensuring a sufficient vaccine supply is critical. Not only does this partnership enable local manufacturing in India, but it also expands our global footprint. Our goal is to produce 100 million doses annually by the end of the decade, with Bio E contributing half. Additionally, Bio E will be our sole manufacturer of multi-dose vials.”

 

At present, the company’s German facility manufactures only single-dose vials, whereas Bio E will produce both single- and multi-dose formats. Multi-dose vials are favoured in public health programmes as they lower costs, improve storage efficiency, and ease distribution. 

TAK-003 is not a standalone solution to dengue

According to WHO, dengue vaccination should be considered one element of a broader, integrated disease control strategy. This includes effective vector control measures, appropriate case management, and active community education and engagement.

 

While the vaccine is a huge leap forward, it’s not a silver bullet. Medical experts say mosquito control measures like clean water storage and avoiding stagnant water will still be critical. 

Why the dengue vaccine launch is critical for India

Dengue cases have been rising steadily across the country. According to the National Center for Vector Borne Diseases Control (NCVBDC) of the Ministry of Health and Family Welfare (MoHFW), in 2024 alone, India reported over 230,000 dengue cases and 236 related fatalities.

 

Now, with the vaccine rollout on the horizon, India is gearing up to protect its population in a big way.  For more health updates and wellness insights, follow #HealthWithBS