‘Made in India’ dengue vaccine likely to be launched next year. Here’s what we know

India may soon see a major leap forward in its battle against dengue, as a ‘Made in India’ version of the vaccine ‘Qdenga’ could be launched as early as next year.

The vaccine, originally developed by Japanese pharmaceutical company Takeda, is being manufactured in India through a collaboration with Hyderabad-based firm Biological E. As per a report by The Times of India, it is likely to be available by 2026 under the government’s ‘Make in India’ initiative.

Over the past few years, India has witnessed a troubling surge in dengue cases, leading to increased hospitalisations and fatalities. In 2023 alone, nearly 3 lakh cases were reported across the country, highest in the last 5 years, as per the information provided by the National Centre for Vector Borne Diseases Control.

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Given the scale of the disease and its impact across India, the arrival of this dengue vaccine could prove to be a game-changer.

Here’s what we know so far about Qdenga.

What is Qdenga, and how does it work?

Dengue fever is a viral infection spread by the Aedes Aegypti mosquito. The virus has four distinct strains — DENV-1 to DENV-4 — which has long made developing an effective vaccine particularly challenging.

That’s where Qdenga, also known as TAK-003, comes in. This live-attenuated vaccine contains weakened forms of all four dengue virus serotypes and is designed to offer broad protection. It’s administered in two doses, given three months apart.

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“TAK-003 showed an excellent safety profile, and the immunogenicity after two doses against the four DENV serotypes was higher than 90 per cent among both adults and children/adolescents who were either seronegative or seropositive at baseline,” researchers noted in a review published in the journal Vaccines, based on clinical trial data from multiple countries.

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For context, “seropositive” individuals have previously been exposed to dengue, while “seronegative” individuals haven’t, making the vaccine’s performance across both groups especially effective.

As per Economic Times, Takeda’s work on a dengue vaccine dates back to the 1980s, beginning with studies in Thailand. The company later joined hands with the US Centers for Disease Control and Prevention (CDC). In 2012, it launched one of its largest clinical trials — the TIDES study — which included 20,000 children across eight dengue-endemic nations. This was published alongside four-and-a-half years of follow-up data in The Lancet in 2023.

In May 2024, the World Health Organization (WHO) granted prequalification status to Qdenga, after reviewing 19 studies that showed the vaccine reduced dengue cases by over 50 per cent.

With the WHO’s green light, global agencies like UNICEF and the Pan American Health Organization could procure the vaccine. Qdenga has already been approved in several countries, including Brazil, Indonesia, Thailand, Argentina, and across the European Union.

Since its launch in 2023, more than 10 million doses of the vaccine have been administered.

All about its launch in India

Qdenga is currently undergoing clinical trials in India to gather local safety data, Derek Wallace, president of Takeda’s global vaccine business unit, told The Times of India.

“We’ve already submitted a comprehensive data package that supported registration in 40 countries, and we anticipate the vaccine will be licensed in India in 2026,” he said.

Wallace also confirmed that the vaccine will be launched simultaneously in both the private and public sectors.

“Like in many other countries, India’s National Immunisation Program is very paediatric-focused. The initial conversation aligns with WHO guidelines for implementing public programs for the paediatric population. However, we are introducing the vaccine in the private sector for both paediatric and adult populations,” he added.

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The Indian rollout will be supported by Hyderabad-based Biological E, which will locally manufacture the vaccine. While Takeda’s German facility currently produces single-dose vials, Bio E will handle the production of both single- and multi-dose formats for the Indian market.

“Our goal is to produce 100 million doses annually by the end of the decade, with Bio E contributing half of that,” Wallace said. Bio E will also become Takeda’s exclusive manufacturer for multi-dose vials, formats that are preferred in government health programmes due to their affordability, easier storage, and simpler logistics.

With input from agencies