The Drugs Controller General of India (DCGI) has approved Biological E. Limited for conducting Phase 3 trials of its COVID-19 vaccine CORBEVAX, after the review of its Phase 1 and 2 clinical trials.
This follows the approval given to the Hyderabad-based company on September 1 to initiate the Phase 2 and 3 study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the vaccine in children and adolescents. This vaccine is an RBD protein subunit vaccine.
“Department of Biotechnology through Mission COVID Suraksha launched under Atma Nirbhar Bharat package 3.0, being implemented by BIRAC, is committed to the development of safe and efficacious COVID-19 vaccines. We look forward to the clinical development of candidate CORBEVAX for paediatric and adults,” said Dr Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairman of its public sector undertaking, Biotechnology Industry Research Assistance Council (BIRAC).
Managing Director of Biological E., Mahima Datla, said, “We are delighted to receive these significant approvals from the DCGI. These approvals encourage our organisation to move forward and successfully produce our COVID-19 vaccine to meet the vaccination needs.”
Mission COVID Suraksha Program is one of the many initiatives that the Department of Biotechnology has taken to increase investments in research, development and the manufacture of COVID-19 vaccines. This program will reinforce and streamline available resources towards accelerated vaccine development, leading to bringing in a safe, efficacious, affordable, and accessible COVID-19 vaccine for the citizens at the earliest.
The Department of Biotechnology and Biotechnology Industry Research Assistance Council have supported Biological E.’s COVID-19 vaccine right from the preclinical stage. In addition to receiving financial assistance under Mission COVID Suraksha, CORBEVAX has also obtained financial support under COVID-19 Research Consortia through the National Biopharma Mission of BIRAC.