Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said today.
Corbevax, an RBD protein sub-unit vaccine, has been developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC), it said.
The approval of the Drugs Controller General of India (DCGI) for conducting phase III comparator safety and immunogenicity trial in adults came after the Subject Expert Committee's (SEC) review of Phase I and II clinical trials data.
"Additionally, Biological E also received approval on 01.09.2021 to initiate Phase II/III study to evaluate safety, reactogenicity, tolerability and immunogenicity of Corbevax vaccine in children and adolescents," the DBT said.
Mahima Datla, Managing Director of Biological E. Limited, said these approvals would help support its subsequent filings with the World Health Organization (WHO) as well.
So far, indigenously developed Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D has received emergency use authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
The DCGI in July granted permission to the Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.
The development of Corbevax was supported by the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) from preclinical stage to phase III clinical studies, the DBT said.
"We look forward to the clinical development of candidate Corbevax for paediatric and adults," DBT Secretary Renu Swarup said.
Ms 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.
"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," she said.