The Nation’s first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila has been approved by Drugs Controller General of India (DCGI), for conduct of Phase III clinical trials. The candidate has been supported by the National Biopharma Mission (NBM) under the aegis of BIRAC and the Department of Biotechnology, Government of India.
Zydus Cadila completed Phase-I/II clinical trials of this DNA Vaccine candidate, in India, in more than 1,000 participants and interim data indicated that the vaccine is safe and immunogenic when three doses were administered intradermally. Based on the recommendations of the Subject Expert Committee, which reviewed the interim data, the DCGI has accorded permission for conducting Phase-III clinical trial in 26,000 Indian participants.
Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC expressed happiness and hoped that the candidate vaccine continues to show positive outcomes. Speaking on the occasion, she said, “The Department of Biotechnology, Government of India has partnered with Zydus Cadila, to address the need for accelerated development of an indigenous vaccine for COVID-19. The partnership exemplifies that such research endeavours demonstrate the Government’s focus on creating an ecosystem that nurtures and encourages new product innovation with societal relevance”. She also mentioned, “The establishment of the Nation’s first DNA vaccine platform is an important milestone for Atma Nirbhar Bharat and a big leap forward for Indian scientific research.”