India’s armoury of vaccines against Covid-19 has got a new weapon, with the Drug Controller General of
India (DCGI) approving Emergency Use Authorisation (EUA) for Hyderabad-based Biological E Limited’s CORBEVAX. The vaccine has been approved for administration both to adults and children in the age group of 12-18.
The Department of Biotechnology (DBT) and its Public Sector Undertaking (PSU), Biotechnology Industry Research Assistance Council (BIRAC), have supported the development of the vaccine from the pre-clinical stage through Phase III clinical studies. The support was given in two steps: first under the COVID-19 Research Consortium programme, through the National Biopharma Mission, for pre-clinical studies and phase I/II clinical trials, and then through Mission COVID Suraksha for further clinical development. It is a 2-dose vaccine administered intramuscularly and can be stored at temperatures ranging from 2ºC to 8ºC.
The Drug Controller General of India has earlier approved it for restricted use in emergencies among adults on December 28, 2021. Now, based on interim results of the ongoing phase II/III clinical study, it has received approval for restricted use in an emergency in adolescents aged 12-to-18-year age group also. 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, said “the department through Mission COVID Suraksha launched under Atma Nirbhar Bharat package 3.0 and 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.”
Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “We are delighted with this important development, which helps our CORBEVAX 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 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.”
