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The Indian Council of Medical Research (ICMR) and Panacea Biotec on Wednesday announced the commencement of Phase 3 clinical trials of India’s first indigenous dengue vaccine, Dengial, at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.
Union Health Minister JP Nadda praised the initiative, saying, “The start of Phase 3 clinical trials for India’s first indigenous dengue vaccine marks a significant progress in our fight against dengue.”
Emphasizing the significance of collaboration between ICMR and Panacea Biotec for the development of dengue vaccine, the Union Health Minister said that “Through this partnership, we are not only taking a step towards ensuring the health and well-being of our people but also strengthening our vision of Aatmanirbhar Bharat in the healthcare sector.”
Currently, there is no antiviral treatment or licensed vaccine for dengue in the country, making the development of an effective vaccine a complex and urgent need. The challenge lies in achieving high efficacy across all four serotypes of the dengue virus, which are known to circulate or co-circulate in many regions of the country.
The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials globally. Of the three Indian companies to receive this strain, Panacea Biotec has made the most progress in developing a complete vaccine formulation.
The company has a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, showing promising results.
The Phase 3 clinical trial, conducted in collaboration with ICMR, will take place at 19 sites across 18 states and union territories, involving over 10,335 healthy adult participants.
It is important to note that dengue is a major public health concern in India, which ranks among the top 30 countries with the highest number of cases of the disease. According to WHO reports, about 75-80% of infections in India are asymptomatic, yet these individuals can spread the infection through the bite of Aedes mosquitoes. In the 20-25% of cases where symptoms are clinically evident, children are at a significantly higher risk of hospitalisation and mortality.
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