Indian-Made Dengue Vaccine Enters Final Trial Phase, Offering Hope for Global Epidemic Control
New Delhi, India — As dengue fever surges globally, an Indian vaccine candidate, DengiAll, developed by Panacea Biotec, has entered the final stage of testing, raising hopes for one of the world’s first single-dose shots against the deadly mosquito-borne disease. The trials are being overseen by the Indian Council of Medical Research (ICMR).
The Growing Dengue Threat
Dengue, which causes severe flu-like symptoms and debilitating body aches, is expanding globally, fueled by rising temperatures and densely populated cities. The World Health Organization (WHO) estimates that almost half the world’s population is now at risk, with 100–400 million infections occurring each year. India alone has recorded over one million cases and at least 1,500 deaths since 2021.
DengiAll: A Potential Breakthrough
Panacea Biotec has initiated Phase III trials of DengiAll, a vaccine nearly 15 years in the making. More than 10,000 volunteers across India are participating in the study, with the vaccine potentially available as early as next year if trial results are favorable. Syed Khalid Ali, chief scientific officer of Panacea, stated the company aims for rapid rollout if the trials are successful.
India’s Dengue Landscape
Doctor Ekta Gupta, professor of clinical virology at the Institute of Liver and Biliary Sciences in New Delhi, notes that dengue is now considered hyperendemic in India, with all four virus serotypes circulating simultaneously. “This vaccine is very much needed right now to control the occurrence of these cases, or at least prevent the severity,” she said.
Climate Change and Dengue Transmission
Monsoon outbreaks regularly strain Indian hospitals, particularly in urban areas, while rural regions face challenges with late diagnoses and limited access to care. Higher temperatures and changing rainfall patterns create ideal breeding conditions for Aedes mosquitoes, the vectors of dengue.
Vulnerability and Vaccine Challenges
Children are particularly vulnerable to the more severe form of dengue, dengue hemorrhagic fever, due to their susceptibility to low platelet counts and shock. Developing vaccines against all four dengue serotypes has been a significant scientific hurdle, as immunity to one strain doesn’t protect against others, and subsequent infections can be more severe. Most existing vaccine candidates require multiple doses.
A First for India and Lower-Middle Income Countries
DengiAll is positioned to be the first single-dose dengue vaccine available in India, where no dengue shot is currently licensed for public use. Ali stated that, “We will be the second (single-dose) vaccine to reach out… But in India and several lower-middle-income countries, we will be the first ones to roll out the dengue vaccine.” The vaccine is based on a tetravalent strain originally developed by the US National Institutes of Health, with Panacea Biotec developing its own formulation and securing a process patent.
Rigorous Testing and Safety Measures
Panacea Biotec emphasizes a cautious approach to vaccine development, prioritizing purity, safety, and minimizing adverse effects. Doctor Priyanka Priyadarsiny, head of biological R&D at Panacea, explained that the product must meet stringent regulatory specifications before being considered safe for public use.
Current WHO Recommendations
Currently, the WHO recommends only one dengue vaccine, Qdenga, produced by Japan’s Takeda, for children aged six to 16 in high-transmission settings. Qdenga, which requires two doses administered three months apart, is not currently available in India.
Future Outlook and Regulatory Approvals
Ali anticipates DengiAll could be administered to individuals aged one to 60 and is expected to provide long-term protection. Final approval in India will come from the Drug Controller General of India, while WHO prequalification is necessary for large-scale international distribution. Experts believe a successful, affordable, Indian-made vaccine could be crucial for mass rollout in lower-income countries.
But, Ali cautioned that Phase III results are essential to confirm the vaccine’s safety and efficacy. “Phase III testing and follow-up are needed to show if the above conditions are met,” he said. “Only then can we have a useful dengue vaccine. It is still early days, but there is hope for the future.”