The vaccine candidate was provided financial support under COVID-19 Research Consortium, through the National Biopharma Mission
India’s first indigenously developed Receptor Binding Domain (RBD) protein subunit vaccine for COVID-19, CORBEVAX, developed by Biological E, 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 the 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.
Dr Rajesh Gokhale, Secretary, Department of Biotechnology, and Chairperson, BIRAC, Government of India, speaking on the subject said that “the Department through Mission COVID Suraksha launched under AtmaNirbhar Bharat package 3.0 being implemented by BIRAC, is committed to the 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, MD, Biological E, 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 the 12-18 age group. With this approval, we are even closer to finishing our global fight against the COVID-19 pandemic. We thank the Department of Biotechnology (DBT) of the Government 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 & clinical site staff who have extended their support during the last several months.”
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