Zydus Cadila gets DCGI approval for Phase III trial of potential Covid vaccine

New Delhi: Phase III clinical trials of indigenously developed country’s first DNA vaccine have been approved by the Controller General of Pharmaceuticals of India (DCGI) against Covid-19, ZYCov-D by M / s Gedus Cadila. This vaccine has been supported by the National Biopharma Mission (NBM) under the aegis of BIRAC and the Department of Biotechnology, Government of India.

Gedus Cadila has completed phase-I / II clinical trials of this DNA vaccine in over 1,000 participants in India, and interim data from these trials indicate that the vaccine is safe and resistant to disease when taken at three doses at short intervals. Capacity enhancer. Based on the recommendations of the Subject Expert Committee reviewing these interim data, DCGI has given permission to conduct phase-III clinical trials of this vaccine in 26,000 Indian participants.

Dr. Renu Swaroop, Secretary, DBT and Chairman of BIRAC expressed happiness over this permission and hoped that the vaccine would continue to give positive results even further. Speaking on the occasion, he said, “The Department of Biotechnology, Government of India has partnered with Gedus Cadila to meet the need for rapid development of an indigenous vaccine of Covid-19. This partnership exemplifies the government’s focus on such research efforts to create an ecosystem that is socially relevant while also nurturing and encouraging new product innovation. ” He also noted that “the establishment of the country’s first DNA vaccine platform is an important milestone towards a self-reliant India and a major leap forward in the field of Indian scientific research.”