The approval of DCGI for conducting trial III came after the subject expert committe’s review of clinical trial l and ll.
Etawah. The Drugs Controller General of India (DCGI), on Friday grants permission to Biological E for two clinical trials of the COVID-19 vaccine candidate Corbevax on children above five years and adolescents with this aim to vaccinated the complete population by the end of this year.
The approval of DCGI for directing trial 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. An RBD protein subunit vaccine, corbevax has been developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC).
Additionally, Biological E also received approval on 01.09.2021 to initiate Phase II/III. Mahima Datla, Managing Director, Biological E. Limited , said these approvals would help support its subsequent filings with the World Health Organization (WHO). 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.
We are grateful to BIRAC for their support We appreciate and acknowledge the contribution of all our collaborators for their continued support in this endeavour. And we are also delighted to receive these significant approvals from the DCGI, Delta added. These approvals encourage our organisation to move forward and successfully produce our COVID-19 vaccine to meet the vaccination needs”.