The Drugs Controller General of India (DCGI) has approved Hyderabad-based Biological E. Limited for conducting Phase III comparator safety and immunogenicity trial in adults of its CORBEVAX™ vaccine against COVID-19 after Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data.
This follows the approval given to the company on September 1 to initiate the Phase II/III Study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the vaccine in children and adolescents. The candidate vaccine is an RBD protein subunit vaccine.
Welcoming the approval, Dr. Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairman of its public sector undertaking, Biotechnology Industry Research Assistance Council (BIRAC), said “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.”
Ms Mahima Datla, Managing Director, Biological E. Limited, 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. We are grateful to BIRAC for their support and we are enthused that these approvals would help support our subsequent filings with WHO as well. We appreciate and acknowledge the contribution of all our collaborators for their continued support in this endeavour.’’
The Department of Biotechnology has taken several initiatives to increase investments in research & development (R&D) and the manufacture of COVID-19 Vaccines. The establishment of the Mission COVID Suraksha Program is one such endeavour for COVID-19 vaccine development to 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 with a target of Atmanirbhar Bharat.
The Department of Biotechnology and Biotechnology Industry Research Assistance Council have supported Biological E.’s COVID-19 Vaccine candidate from the preclinical stage. In addition to receiving financial assistance under Mission COVID Suraksha, this vaccine candidate has also obtained financial support under COVID-19 Research Consortia through the National Biopharma Mission of BIRAC.
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