India is close to launching its first indigenous dengue vaccine as Panacea Biotec’s DengiAll enters final Phase III trials, raising hopes for one of the world’s first single-dose shots against the deadly mosquito-borne disease. More than 10,000 volunteers across the country have been enrolled in the study, overseen by the Indian Council of Medical Research, with the shot on track for rollout as early as next year if trial results are favourable.
The development is crucial. Dengue has exploded globally, fuelled by rising temperatures and densely populated cities. The World Health Organization says almost half the world’s population is now at risk, with 100 to 400 million infections every year. India alone has recorded over one million cases and at least 1,500 deaths since 2021. A working dengue vaccine would be a landmark public-health tool.
DengiAll: 15 years in the making
Panacea Biotec has been pursuing the dengue vaccine for nearly 15 years. “We will try to get this vaccine out there as soon as possible,” Syed Khalid Ali, chief scientific officer of Panacea, told AFP in New Delhi. DengiAll is a tetravalent vaccine, meaning it targets all four dengue virus serotypes: DENV-1, DENV-2, DENV-3 and DENV-4.
If approved, DengiAll’s single-dose regimen would be a major advantage. It could simplify vaccination logistics and improve compliance compared with multi-dose vaccines, particularly in rural areas where follow-up visits are difficult to enforce. No pre-vaccination screening would be needed, a practical edge in a country where dengue exposure is widespread.
Dengue vaccine trial: 13,000 volunteers at 20 centres
According to the ICMR, the Phase III dengue vaccine trial is running at 20 institutes across India with over 13,000 volunteers enrolled in a randomised study, where for every two volunteers who received the vaccine, one received a placebo. ICMR Director General Rajiv Bahl said the trial has completed almost a year of follow-up and researchers are hopeful of unblinding the code by the end of next year.
“The trial has completed almost a year of follow-up,” Bahl said on the sidelines of a health oration in Kolkata, adding that results could determine whether the dengue vaccine proceeds to regulatory review and possible approval. Because dengue case numbers have been relatively low this year, the trial team may need longer to accumulate the infection events required to measure efficacy.
Why India needs the shot now
Doctors say the need is urgent. “This vaccine is very much needed right now to control the occurrence of these cases, or at least prevent the severity,” said Dr Ekta Gupta, professor of clinical virology at the Institute of Liver and Biliary Sciences in New Delhi. She noted that dengue is now considered hyperendemic in India, with all four virus serotypes circulating simultaneously.
Separately, India has already approved Qdenga, Takeda’s dengue vaccine, its first-ever licensed shot, with domestic production planned through a manufacturing collaboration with Biological E. But a homegrown single-dose dengue vaccine would give India supply security and an affordable option for mass immunisation.
Dengue vaccine: what happens next
Officials stress that even after a dengue vaccine launches, mosquito-control and prevention measures remain essential. There is no specific treatment for dengue; care is supportive. But a successful Phase III readout by late 2027 could make India the first country with an indigenous single-dose weapon against a disease that puts half the world at risk. India’s dengue burden makes the timeline critical: with over one million cases and at least 1,500 deaths since 2021, and outbreaks intensifying each monsoon, public-health experts say even a phased rollout of an affordable indigenous shot could change the trajectory of seasonal epidemics.
Qdenga approval sets the stage for DengiAll
India has already approved Qdenga, Takeda’s dengue vaccine, as its first-ever licensed shot, with domestic production planned through a manufacturing collaboration with Biological E. Qdenga is approved in 42 countries and requires no pre-vaccination screening, meaning people who have previously had dengue can receive it without first being tested for past infection.
A homegrown single-dose alternative would still be a major win: supply security, potentially lower prices and a vaccine designed around India’s own trial data. Officials stress that even with vaccines on the horizon, mosquito-control and prevention measures remain essential, since there is no specific treatment for dengue and care remains supportive. But a successful Phase III readout by late 2027 could make India the first country with an indigenous single-dose weapon against a disease that puts half the world at risk.