Biological E's ‘Corbevax’ gets DCGI approval for two clinical trials
- Biological E received approval for Phase 3 comparator safety and immunogenicity trial in adults after a review of Phase 1 and 2 clinical trials data by a subject expert committee.
The Drugs Controller General of India (DCGI) has given approval to Biological E for two clinical trials of its Covid-19 vaccine candidate Corbevax, the ministry of science and technology announced Friday. The Hyderabad-based pharmaceutical company received approval for Phase 3 comparator safety and immunogenicity trial in adults after a review of Phase 1 and 2 clinical trials data by a subject expert committee.
It also received approval for the Phase 2/3 study to evaluate the “safety, reactogenicity, tolerability and immunogenicity” of Corbevax in children and adolescents.
Dr Renu Swarup, secretary, the department of biotechnology (DBT), said that the department is committed to the development of safe and efficacious Covid-19 vaccines. Swarup, who is also chairperson of Biotechnology Industry Research Assistance Council (BIRAC), said in a statement that they look forward to the clinical development of Corbevax for paediatric and adults.
Mahima Datla, Managing Director, Biological E. Limited, expressed delight over the “significant approvals” from the DCGI. Datla said in a statement that these approvals encourage the company to move forward and successfully produce the Covid-19 vaccine to meet the country’s 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.
The ministry said that the DBT and BIRAC have supported Corbevax, which is an RBD protein subunit vaccine, from the preclinical stage to Phase 3 clinical studies. The Biological E’s vaccine candidate has also received financial support assistance under Covid-19 Research Consortia through National Biopharma Mission, BIRAC.
On Thursday, Niti Aayog member (health) Dr VK Paul said that results of Phase 3 trials of Corbevax were awaited and the company had committed to supply a significant quantity of the vaccine by the end of the year.
“Stockpile is being produced. We should wait for the results. We hope it’ll be in the next month or two. They’ve made a broad commitment that they’ll supply a significant amount by year-end,” news agency ANI quoted Dr Paul as saying.