Biological E’s ‘Corbevax’ gets DCGI approval for two clinical trials-Covid News
The Department of Biotechnology (DBT) said that Hyderabad-based Biological E has obtained permission from the Indian drug regulator.
It will undertake two independent clinical trials, one on adults and the other on children and adolescents for its covid-19 vaccine candidate, Corbevax.
“Biological E has obtained Drugs Controller General of India (DCGI) permission.
It will conduct a phase 3 comparative safety and immunogenicity study in adults after a review of phase 1 and 2 clinical trial data by a subject expert committee, according to the Ministry of Science and Technology.
“In addition, on September 1st, Biological E obtained permission to begin the phase 2-3 research to assess the safety, automatous, tolerance, and immunological of the Corbevax vaccine in children and adolescents.”
Biological E’s candidate was funded by the Biotechnology Industry Research Assistance Council (BIRAC) from the preclinical stage through phase 3 trials.
This is India’s third vaccine, after Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoVD.
Corbevax is a protein subunit vaccine that consists only of spike proteins that are administered to elicit an immunological response.