Biological E Ltd has received Drugs Controller General of India’s (DCGI) approval for conducting the phase-III Comparator Safety & Immunogenicity trial in adults after Subject Expert Committee’s (SEC) review of the phase-I and-II clinical trials data. Additionally, Biological E received approval on 1 September 2021 to initiate the phase-II/III Study to evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX vaccine in children and adolescents. The candidate is an RBD protein subunit vaccine.
The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E’s Covid-19 vaccine candidate from the preclinical stage to the phase-III clinical studies. In addition to receive financial assistance under the Mission Covid Suraksha, this vaccine candidate has also obtained financial support under the Covid-19 Research Consortia through National Biopharma Mission, BIRAC.
“Department 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, DBT and Chairperson, BIRAC said.
Mahima Datla, Managing Director, Biological E Ltd, “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 the WHO as well. We appreciate and acknowledge the contribution of all our collaborators for their continued support in this endeavour.”