DCGI approves advanced trials for Biological E. Ltd's COVID- 19 vaccine
After reviewing Phase I and II clinical trial data, the Drugs Controller General of India (DCGI) has approved Hyderabad-based Biological E. Limited to conduct a Phase III comparative safety and immunogenicity trial in adults of its CORBEVAXTM vaccine against COVID-19.
This comes after the business received approval on September 1 to begin the Phase II/III Study to assess the vaccine's safety, reactogenicity, tolerability, and immunogenicity in children and adolescents. RBD protein subunit vaccine is the potential vaccine.
“The 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 vaccins,” said Dr. Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairman of its public sector undertaking, Biotechnology Industry Research Assistance Council (BIRAC). We are excited to see candidate CORBEVAXTM enter clinical trials for both children and adults.”
Biological E. Limited's Managing Director, Ms Mahima Datla, stated, "We are thrilled to get these key clearances from the DCGI." These approvals provide our organisation the confidence to move forward and effectively manufacture our COVID-19 vaccine in order to meet the vaccination needs. We are appreciative to BIRAC for their assistance, and we are optimistic that these approvals will support our forthcoming WHO filings. All of our collaborators' contributions are valued and acknowledged, and we thank them for their continuous support in our endeavour.'
The Department of Biotechnology has taken many steps to expand funding in COVID-19 vaccine research and development (R&D) and manufacturing. The foundation of the Mission COVID Suraksha Program is one such effort for COVID-19 vaccine development, with the goal of bringing a safe, efficacious, inexpensive, and accessible COVID-19 vaccine to citizens as soon as possible, with the goal of Atmanirbhar Bharat.
From the preclinical stage, the Department of Biotechnology and the Biotechnology Industry Research Assistance Council have backed Biological E.'s COVID-19 vaccine candidate. In addition to receiving funding under Mission COVID Suraksha, this vaccine candidate has also received funding through the National Biopharma Mission of BIRAC through the COVID-19 Research Consortia.