Hyderabad-based pharmaceutical firm Biological E. has received the Drugs Controller General of India (DCGI) approval for initiating the Phase II/III study to evaluate its CORBEVAX vaccine in children aged above 5 years.
It has also received nod for conducting Phase III trial in adults after a Subject Expert Committee’s (SEC) review of its Phase I and II clinical trials data, a PIB release stated on September 3.
Supported by the Department of Biotechnology, Biological E. has developed CORBEVAX, a RBD protein sub-unit vaccine for coronavirus disease.
The DBT and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E.’s COVID-19 vaccine candidate from pre-clinical stage to Phase III clinical studies. In addition to receiving financial assistance under Mission COVID Suraksha, this vaccine candidate has also obtained a financial support under COVID-19 Research Consortia through National Biopharma Mission, BIRAC.
“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,’’ said Mahima Datla, Managing Director, Biological E. Limited.
