ICMR and Panacea Biotec Launch India’s First Phase 3 Trial for Indigenous Dengue Vaccine
In a significant development in India’s fight against dengue, the Indian Council of Medical Research (ICMR) and Panacea Biotec have commenced the first-ever Phase 3 clinical trial for an indigenous dengue vaccine. The vaccine, named DengiAll, marks a crucial step in the nation’s efforts to develop a homegrown solution to combat this widespread public health threat. The trial’s first participant was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak today.
Union Minister of Health & Family Welfare, Shri J.P. Nadda, hailed this milestone, 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.”
Dengue has long posed a significant public health challenge in India, which ranks among the top 30 countries with the highest incidence of the disease. Despite the widespread prevalence, no antiviral treatment or licensed vaccine is currently available in the country. The complexity of developing an effective dengue vaccine lies in achieving efficacy against all four serotypes of the virus, which circulate widely in India.
DengiAll, developed by Panacea Biotec, is a tetravalent dengue vaccine that has shown promising results in earlier trials. The vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH) in the USA, has been adapted and formulated by Panacea Biotec to meet the specific needs of the Indian population. The company completed Phase 1 and 2 clinical trials in 2018-19, which yielded encouraging results.
The Phase 3 trial, conducted in collaboration with ICMR, will be carried out across 19 sites in 18 States and Union Territories of India, involving over 10,335 healthy adult participants. The trial, primarily funded by ICMR with partial support from Panacea Biotec, will follow up with participants for two years to evaluate the vaccine’s efficacy and safety.
This trial represents not only a critical step in addressing one of India’s most pressing public health challenges but also a testament to the country’s commitment to self-reliance in the healthcare sector, as emphasized by the Atmanirbhar Bharat initiative. With the global incidence of dengue on the rise, the successful development of DengiAll could be a game-changer in the global fight against dengue.
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