The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever Phase 3 clinical trial for a dengue vaccine in India. This landmark trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll,developed by Panacea Biotec. The first participant in this trial was vaccinated today at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.
Commenting on this milestone, Union Minister of Health & Family Welfare, Shri J.P. Nadda, said, “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 tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide.
Panacea Biotec, one of three Indian companies to receive the strain,is at the most advanced stage of development.The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results.
In collaboration with ICMR, Panacea Biotec will conduct the Phase 3 clinical trial across 19 sites in 18 States and Union Territories of India, involving more than 10,335 healthy adult participants.
