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New Delhi : India’s first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for Covid-19, CORBEVAXTM, developed by Biological E Limited, has received approval for Emergency Use Authorization from the Drug Controller General of India (DCGI) for 12-18 years age group. It is approved to be administered in humans including Children and adults 12 years and above.
The Department of Biotechnology (DBT) and its Public Sector Undertaking (PSU), Biotechnology Industry Research Assistance Council (BIRAC), have 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. CORBEVAXTM is a 2-dose vaccine administered intramuscularly and can be stored at 2ºC to 8ºC, according to a PIB release.
The recombinant protein sub-unit vaccine developed from the Receptor Biding Domain (RBD) of the spike protein on the viral surface is adjuvanted with CpG 1018 and alum. The Drug Controller General of India had already approved CORBEVAXTM, for restricted use in emergency situation among adults on December 28, 2021. Based on interim results of the ongoing phase II/III clinical study, Biological E has received approval for restricted use in an emergency situation in adolescents aged 12 to 18 year age group.
The available safety and immunogenicity results of the ongoing phase II/III clinical study indicated that the vaccine is safe and immunogenic. The Translational Health Science and Technology Institute (THSTI), an Autonomous Institute of DBT, provided immunogenicity data for the Phase II/ III studies.
Dr Rajesh Gokhale, Secretary, Department of Biotechnology, and Chairperson, BIRAC, Government of India, speaking on the subject said, “the Department through Mission Covid Suraksha launched under AtmaNirbhar Bharat package 3.0 being implemented by BIRAC, is committed to development of safe and efficacious Covid-19 vaccines. This is the 2nd vaccine, supported under the Mission, to have received EUA for the age group of 12-18 years. Corbevax is based on a time-tested platform and would be an important vaccine for India and the world. This is yet another successful example of industry- academia partnership.”
Mahima Datla, Managing Director, Biological E. Limited, said, “We are delighted with this important development, which helps our CORBEVAXTM reach yet another milestone in extending our Covid-19 immunisation initiative to cover to the 12-18 age group. With this approval, we are even more closer to finishing our global fight against the Covid-19 pandemic. We thank the Department of Biotechnology (DBT) of Govt. of India, Biotechnology Industry Research Assistance Council (BIRAC), Translational Health Science and Technology Institute (THSTI), all the participants in the clinical trials and the principal investigators and clinical site staff who have extended their support during the last several months.”
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures, and supplies vaccine and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccine in its portfolio.