India's First Indigenous Dengue Vaccine Completes Third Phase Trials

In a significant advancement in public health, the Indian Council of Medical Research (ICMR) has announced that enrollment is nearly complete for the third phase of clinical trials for the country’s first indigenous dengue vaccine, DengiAll, developed by Panacea Biotec. As of July 12, 2025, approximately 8,000 of the targeted 10,000 participants have enrolled in this landmark trial, which is being conducted at 20 centers across India, including major cities such as Chennai, Pune, Hyderabad, and Delhi. According to Manoj Murhekar, Director of the National Institute of Epidemiology at ICMR, the trial aims to evaluate the efficacy of this tetravalent vaccine against all four serotypes of the dengue virus, which poses a significant public health threat in India.

Dengue fever, transmitted by Aedes mosquitoes, has seen a steady increase in incidence, with India ranking among the top 30 countries affected by the disease. As reported by the World Health Organization (WHO), more than 129 countries reported cases of dengue by the end of 2023, underscoring the global nature of the crisis. Currently, there are no antiviral treatments or licensed vaccines available for dengue in India, making this trial crucial. The vaccine strain, TV003/TV005, was developed by the National Institutes of Health in the U.S. and has shown promising results in both preclinical and clinical settings worldwide.

The ICMR is primarily funding the trial, with partial support from Panacea Biotec. Participants in this trial will be monitored for two years to assess the vaccine's long-term efficacy and safety. The first participant was vaccinated last year at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak, marking a pivotal moment in India's fight against dengue.

Dr. Murhekar emphasized the importance of developing an effective vaccine, stating, "In India, all four serotypes of the dengue virus circulate or co-circulate in many regions, so it’s vital to ensure that we have an effective vaccine that achieves good efficacy for all four serotypes."

Previous phases of the clinical trials, completed in 2018-2019, yielded promising data, which has set the stage for this crucial third phase. The ongoing trials could lead to the availability of a vaccine that not only protects against dengue fever but also reduces the incidence of severe forms of the disease, which disproportionately affect children and can lead to hospitalization and potential mortality.

The social implications of a successful dengue vaccine are profound. Currently, 75-80% of dengue infections in India are asymptomatic, yet these individuals can transmit the virus, complicating efforts to control outbreaks. Moreover, children face a significantly higher risk of severe outcomes from the disease, and adults can develop severe conditions such as dengue hemorrhagic fever and dengue shock syndrome. Thus, a successful vaccine could dramatically alter the landscape of dengue management in India.

Looking ahead, experts urge that, if proven effective, DengiAll could become a cornerstone in public health strategies aimed at controlling dengue in India and potentially in other affected countries. The trial’s outcomes will not only influence public health policy but also provide a model for future vaccine development against other mosquito-borne illnesses, illustrating the interconnection between research, public health, and the potential for innovative solutions in tackling infectious diseases.

Ultimately, while the ongoing trials represent a beacon of hope in the fight against dengue, they also serve as a reminder of the need for sustained investment in vaccine research and development, particularly in regions where vector-borne diseases pose a significant threat to public health. As the world continues to grapple with the ramifications of infectious diseases, the outcomes of India’s dengue vaccine trials may hold vital lessons for global health initiatives in the years to come.