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Rohtak, August 15, 2024 — In a significant stride towards combating dengue, the Indian Council of Medical Research (ICMR) and Panacea Biotec have launched the first-ever Phase 3 clinical trial for an indigenous dengue vaccine, DengiAll. This marks a critical milestone in India’s ongoing efforts to control a disease that has plagued millions across the country.
Union Minister of Health & Family Welfare, Shri J.P. Nadda, highlighted the importance of this trial, stating, “The initiation of this Phase 3 clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India’s capabilities in vaccine research and development. Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector.”
The trial’s first participant was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak, Haryana. This trial is expected to be a game-changer in India’s public health landscape, potentially providing the nation with its first licensed dengue vaccine.
A Collaborative Effort in Vaccine Development
Panacea Biotec, a leading Indian biopharmaceutical company, has developed DengiAll, a tetravalent dengue vaccine designed to protect against all four serotypes of the dengue virus. The vaccine strain, originally developed by the National Institutes of Health (NIH) in the United States, has shown promising results in preclinical and clinical trials globally. Panacea Biotec, among the three Indian companies licensed to develop this vaccine strain, has made significant advancements, culminating in the formulation of DengiAll.
Phase 1 and 2 clinical trials, completed in 2018-19, demonstrated encouraging safety and efficacy profiles, paving the way for this Phase 3 trial. The trial will be conducted across 19 sites in 18 States and Union Territories, involving over 10,335 healthy adult participants. This large-scale study is primarily funded by ICMR, with additional support from Panacea Biotec. The participants will be monitored for two years, providing critical data on the vaccine’s long-term efficacy and safety.
Addressing a Major Public Health Concern
Dengue remains a significant public health challenge in India, with the country ranking among the top 30 globally for dengue incidence. According to the World Health Organization (WHO), the global incidence of dengue has surged over the past two decades, with over 129 countries reporting cases by the end of 2023. In India, the dengue virus is prevalent, with all four serotypes circulating in various regions.
A major challenge in dengue prevention is the virus’s complexity. The disease can be asymptomatic in up to 80% of cases, but symptomatic cases can lead to severe complications, particularly in children. Without a licensed vaccine or antiviral treatment, dengue control has largely relied on vector management and public health initiatives.
A Step Towards Atmanirbhar Bharat
The development of DengiAll aligns with India’s broader vision of Atmanirbhar Bharat, or self-reliant India, particularly in the healthcare sector. By advancing indigenous vaccine development, India is not only addressing a critical public health issue but also enhancing its capabilities in biomedical research and innovation.
The successful completion of this Phase 3 trial could pave the way for the widespread use of DengiAll, offering hope to millions at risk of dengue in India and potentially in other dengue-endemic regions worldwide. As India moves forward with this groundbreaking trial, it stands on the brink of a significant breakthrough in the fight against dengue, demonstrating its resolve to protect its citizens and contribute to global health security.
