Biological E gets nod for phase 2/3 clinical trial

New Delhi, Sept. 3: Biological E has received approval for conducting phase II/III human clinical trial of Covid-19 vaccine candidate Corbevax on children above 5-years and adolescents, the department of biotechnology (DBT) said on Friday. Corbevax, an RBD protein sub-unit vaccine, has been developed with supported from the department of biotechnology and its PSU biotechnology industry research assistance council (BIRAC), it said.

The approval of the Drugs Controller General of India (DCGI) for conducting phase 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.

“Additionally, Biological E also received approval on 01.09.2021 to initiate Phase II/III study to evaluate safety, reactogenicity, tolerability and immunogenicity of Corbevax vaccine in children and adolescents,” the DBT said.

Mahima Datla, managing director Biological E. Limited, said these approvals would help support its subsequent filings with the World Health Organisation (WHO) as well.

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. The DCGI in July had granted permission to Serum Institute of India for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions. —