New Delhi: Japanese drugmaker Takeda is on track to manufacture up to 50 million doses of its dengue vaccine Qdenga annually in India by 2030—half of its planned 100 million-dose global manufacturing capacity—Peter Streibl, General Manager for Southeast Asia and India Cluster at Takeda, told ThePrint Tuesday.
Hyderabad-based vaccine maker Biological E is expected to manufacture the doses through multi-dose vials. “These are intended to support government procurement and public immunisation programmes in dengue-endemic countries,” Streibl said.
Qdenga is currently manufactured at Takeda’s Singen facility in Germany. In July this year, India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO) approved Qdenga, making it the country’s first authorised dengue vaccine.
It is approved for people aged 4 to 60 years, regardless of whether they have previously had dengue, and is given in two doses three months apart.
The vaccine has been approved in 43 countries, and more than 30 million doses have been distributed globally since its launch in 2022.
But Indians will have to wait until next year to access the vaccine commercially. Streibl said that Takeda is completing the remaining regulatory steps, including the import licence, pricing and quality-release processes. “We are confident that in the first half of 2027, we’ll make it available,” he told ThePrint.
Qdenga is designed to protect against all four dengue virus serotypes. While the vaccine is expected to be available through the private sector initially, Takeda is also seeking eventual inclusion in India’s Universal Immunisation Programme (UIP).
Earlier, a parliamentary committee had recommended that the government consider including Qdenga in the UIP.
Streibl said the decision on including Qdenga in the Universal Immunisation Programme would rest with the government and its expert and empowered committees, with Takeda providing scientific and technical inputs. In the meantime, the company is working to make the vaccine available through private, public, endemic-market and travel channels.
Takeda has not disclosed the vaccine’s price. Streibl said the company was committed to “broad, equitable, timely and sustainable access” at a cost that reflects QDENGA’s health, societal and economic benefits.
Dengue is caused by four virus serotypes and spread by Aedes mosquitoes. It is endemic in more than 100 countries, putting nearly half the world’s population in tropical and subtropical regions at risk. Most infections are mild, but a second infection with a different serotype can increase the risk of severe disease.
In India, dengue is now endemic across most parts of the country. Transmission has increased about 11-fold over the past two decades, with India accounting for nearly one-third of the global dengue burden.
Climate models suggest that by 2050, global warming could put 1.3–1.5 billion people worldwide at risk of dengue, with India likely to face longer transmission seasons and the spread of the disease to previously cooler, higher-altitude areas.
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Decades in development
QDENGA’s development goes back more than six decades. Takeda’s dengue vaccine programme traces its origins to a dengue patient presented for treatment at Prince Mahidol University in Thailand in 1964.
Streibl said researchers weakened a DENV-2 virus in the early 1980s. This weakened virus later became the backbone of QDENGA, with components from the other three dengue virus types added to make it protect against all four serotypes.
“Dengue is a complex disease. It’s actually four diseases basically in one,” Streibl said.
The vaccine has been evaluated through 19 clinical trials involving more than 28,000 participants across 13 countries. Its pivotal Phase III TIDES trial enrolled more than 20,000 participants and included people with and without previous dengue infection.
At 12 months after the second dose, Qdenga showed 80.2 percent efficacy against virologically confirmed dengue. At 18 months, it showed 90.4 percent efficacy against dengue-related hospitalisation. Longer-term follow-up showed 61.2 percent efficacy against confirmed dengue and 84.1 percent efficacy against dengue-related hospitalisation over 4.5 years.
Seven-year follow-up data was also generated to monitor rare safety signals and assess the vaccine’s longer-term benefit-risk profile.
Safety has been a key concern in dengue vaccine development because of the risk of antibody-dependent enhancement (ADE), in which antibodies from an earlier infection can, in some cases, worsen a later infection.
In the TIDES trial, participants were tested for previous dengue infection, and there was no evidence that Qdenga increased disease severity, including among those who had never had dengue.
Qdenga was also tested in India in the Phase III DEN-302 trial, which included 480 healthy participants aged 4 to 60. Their immune responses were consistent with those seen in global trials, and the vaccine’s safety profile was similar to earlier studies.
The Indian regulator approved Qdenga for people aged 4 to 60 based on the clinical evidence submitted by Takeda.
Unlike French drugmaker Sanofi’s Dengvaxia, which was linked to safety concerns in people who had not previously been infected with dengue and led to restrictions on its use, Qdenga does not require testing for prior dengue infection before vaccination.
Takeda says this is because Qdenga was studied in both people who had and had not previously been infected with dengue.
Protection, not perfection
Asked what the 80.2 percent efficacy figure means for an individual’s risk of developing dengue after vaccination, Streibl said it represents a relative reduction in risk over a defined period, rather than a guarantee that a person will not get dengue.
“An 80.2 percent efficacy result means that, during that defined study period, the vaccine reduced the risk of virologically confirmed dengue by 80.2 percent,” he said. “To simplify in layman’s language, Qdenga prevented approximately eight out of 10 cases of virologically confirmed dengue.”
Some vaccinated people may still develop dengue, he said, but their risk is substantially reduced.
“No vaccine provides 100 percent protection against every infection, and that does not mean the vaccine is ineffective,” he said.
He added that dengue is a complex disease involving four circulating serotypes and Qdenga has demonstrated strong protection against the outcomes that matter most in dengue, especially severe disease and hospitalisation.
The need for a dengue vaccine comes as the disease’s geographical and seasonal spread expands. Rapid urbanisation, population movement and changing climate conditions are creating more favourable environments for Aedes mosquitoes and extending the areas and seasons in which dengue can spread.
There is also no specific antiviral treatment for dengue, with care largely focused on managing symptoms and preventing complications. This makes prevention through mosquito control, surveillance, early diagnosis and vaccination important to reducing the disease burden.
Streibl said Takeda sees vaccination as an additional layer of protection, rather than a replacement for existing dengue-control measures.
“The best way to get a hold of the disease is prevention and control. And immunisation and vaccination have a very strong part in it,” Streibl said.
He said vaccination needs to work alongside vector control, disease surveillance, community engagement, early diagnosis and appropriate case management. Personal protection will also remain important because Aedes mosquitoes are active during the daytime.
This includes using repellents, wearing clothing that covers the arms and legs, and using window and door screens.
“Removing stagnant water, covering water-storage containers, and proper waste management will also remain important to reduce mosquito breeding,” he said.
(Edited by Sugita Katyal)
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