New Delhi: Biological E has received the Drugs Controller General of Indias' (DCGI) approval for conducting Phase 3 comparator safety and immunogenicity trial of its Corbevax vaccine in adults after the subject expert committee's (SEC) review of Phase 1 and 2 clinical trials data.
Additionally, Biological E also has received approval to initiate the Phase 2/3 study to evaluate safety, reactogenicity, tolerability and immunogenicity of the vaccine in children above 5 years of age.
The Hyderabad-based pharmaceutical firm's Corbevax is a RBD protein sub-unit vaccine.
The Department of Biotechnology and its PSU, the Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E's Covid-19 vaccine candidate from pre-clinical stage to Phase 3 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 the BIRAC's National Biopharma Mission.
Secretary, Biotechnology, and BIRAC Chairperson, Dr Renu Swarup, said that her department, through Mission Covid Suraksha launched under Atma Nirbhar Bharat package 3.0, "is committed to development of safe and efficacious Covid-19 vaccines. We look forward to the clinical development of candidate Corbevax for paediatric and adult use".
Biological E Managing Director Mahima 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 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 added.