India

Biological E gets nod for phase 2/3 clinical trial of its Covid vaccine on kids, adolescents | India News – Times of India


NEW DELHI: Biological E has acquired approval for conducting phase II/III human clinical trial of Covid-19 vaccine candidate Corbevax on kids above 5 years and adolescents, the Department of Biotechnology (DBT) mentioned on Friday.
Corbevax, an RBD protein sub-unit vaccine, has been developed with help from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC), it mentioned.
The approval of the Drugs Controller General of India (DCGI) for conducting phase III comparator security and immunogenicity trial in adults got here after the Subject Expert Committee’s (SEC) evaluation of Phase I and II clinical trials information.
“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 mentioned.
Mahima Datla, Managing Director, Biological E. Limited, mentioned these approvals would assist help its subsequent filings with the World Health Organization (WHO) as properly.
So far indigenously developed Zydus Cadila’s needle-free Covid-19 vaccine ZyCoV-D has acquired emergency use authorisation from the drug regulator, making it the primary vaccine to be administered within the age group of 12-18 years within the nation.
The DCGI in July had granted permission to the Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on kids aged 2 to 17 years with sure circumstances.
The growth of Corbevax was supported by the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) from preclinical stage to phase III clinical research, the DBT mentioned.
“We look forward to the clinical development of candidate Corbevax for paediatric and adults,” DBT secretary Renu Swarup said.
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 the 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,” Datla mentioned.



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