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The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drug trials and approvals, has recommended grant of permission to Biological E to conduct phase III clinical trial of Covid-19 vaccine Corbevax in 5 to 80 years old individual.
The recommendation has been made after the company presented the phase –III clinical trial protocol titled - A prospective single-blind randomized phase-III comparative study to evaluate immunogenicity and safety of its XBB 1.5-Receptor Binding Domain (RBD) sub-unit Covid-19 vaccine in 5-80 years old Individual.
The SEC for consideration and recommendations of Covid-19 vaccines, in its meeting held on December 7, deliberated on the proposal and recommended grant of permission to conduct the phase III clinical trial as per the protocol presented by the company.
The Committee noted that a permission in the clinical trial was already granted to the firm for SARS-CoV-2 vaccine containing RBD of SARS-CoV-2 gene (Corbevax) in the age group of between five to 12 years and 12 to 18 years old individuals.
Corbevax, according to the Ministry of Science and Technology, is India's first indigenously developed RBD protein subunit vaccine for Covid-19 developed by Biological E Ltd. The Drugs Controller General of India approved the vaccine under Emergency Use Authorisation (EUA) for adults in December, 2021 and for 12-18 years age group, in February, 2022.
The Department of Biotechnology (DBT) and its Public Sector Undertaking (PSU), Biotechnology Industry Research Assistance Council (BIRAC), supported Biological E’s Covid-19 vaccine candidate from pre-clinical stage through phase III clinical studies.
The vaccine candidate was provided financial support under Covid-19 Research Consortium, through the National Biopharma Mission, for pre-clinical studies and phase I/II clinical trials. Additional support was provided through Mission Covid Suraksha for further clinical development. Corbevax is a 2-dose vaccine administered intramuscularly and can be stored at 2ºC to 8ºC.
The recombinant protein sub-unit vaccine developed from the RBD of the spike protein on the viral surface is adjuvanted with CpG 1018 and alum. Based on interim results of the phase II/III clinical study, Biological E also earlier received approval for restricted use in an emergency situation in adolescents aged 12 to 18 year age group, said MST in early 2022. The Translational Health Science and Technology Institute (THSTI), an Autonomous Institute of DBT, provided immunogenicity data for the phase II/ III studies.
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