ICMR, Panacea Biotec embark on Phase 3 Clinical Trial for Indigenous Dengue Vaccine

Union Minister of Health & Family Welfare, Shri J.P. Nadda, hailed the commencement of this Phase 3 trial as a pivotal moment in the battle against dengue.

The Indian Council of Medical Research (ICMR) and Panacea Biotec have embarked on a groundbreaking Phase 3 clinical trial for India's first indigenous dengue vaccine, DengiAll. This significant trial began today with the vaccination of its first participant at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.

Union Minister of Health & Family Welfare, Shri J.P. Nadda, hailed the commencement of this Phase 3 trial as a pivotal moment in the battle against dengue. "The launch of this clinical trial for India's first homegrown dengue vaccine represents a major leap forward in our fight against the disease. It demonstrates our commitment to safeguarding public health and showcases India's growing prowess in vaccine research and development. This collaboration between ICMR and Panacea Biotec is a crucial step towards ensuring the health and well-being of our citizens and reinforces our vision of Atmanirbhar Bharat in the healthcare sector," Nadda stated.

Currently, India lacks an antiviral treatment or licensed vaccine for dengue, a challenge compounded by the need to cover all four dengue virus serotypes. The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH), USA, has shown promise in trials worldwide. Panacea Biotec, one of three Indian firms to receive the strain, is now at the forefront of its development. The company has advanced the formulation through extensive research and holds a process patent for its work. Previous Phase 1 and 2 trials, completed in 2018-19, demonstrated encouraging results.

The Phase 3 trial, a joint effort between ICMR and Panacea Biotec, will be conducted across 19 sites in 18 States and Union Territories of India, involving over 10,335 healthy adult participants. Funded primarily by ICMR with partial support from Panacea Biotec, the trial will track participants for two years. This initiative is a major step towards developing a homegrown vaccine to address one of India's significant public health issues and embodies the nation's dedication to Atmanirbhar Bharat.