2. INDIGENOUSLY DEVELOPED DNA VACCINE CANDIDATE
DBT-BIRAC supported indigenously developed DNA Vaccine Candidate by ZydusCadila, approved for Phase III clinical trials.
- India’s first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by ZydusCadila has been approved by the Drugs Controller General of India (DCGI), for the 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.
- After phase I and II trials, ZydusCadila’s 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.
- BIRAC Biotechnology Industry Research Assistance Council (BIRAC), set up under the Dept. of Biotechnology (DBT), is supporting the vaccine manufacturing platform establishment under the National Biopharma Mission.