Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above
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 on Friday.
Corbevax, an RBD protein sub-unit vaccine, has been developed with supported from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC), it said.
PTI had first reported the grant of approval to Biological E for trial of its vaccine candidate on Wednesday.
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, 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.
