Department of Biotechnology Mission COVID Suraksha Supported Biological E Limited Novel COVID-19 vaccine candidate – CORBEVAXTM receives DCGI approval for Emergency Use Authorization

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 the Drug Controller General of India (DCGI) approval for Emergency Use Authorization (EUA).

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 toxicology studies. Later support was provided under Mission COVID Suraksha for clinical development. CORBEVAXTM is a 2-dose vaccine administered intramuscularly and can be stored at 2ºC to 8ºC.

The recombinant protein sub-unit vaccine developed from the Receptor Biding Domain (RBD) of the spike protein on the viral surface is adjuvanted with Dynavax’s CpG 1018 and alum. Comprehensive Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India, demonstrated the vaccine to be safe, well tolerated and highly immunogenic. The Translational Health Science and Technology Institute (THSTI), an Autonmous Institute of DBT, provided key immunogenicity data for the Phase II/ III studies.

Dr Rajesh Gokhale, Secretary, Department of Biotechnology, Government of India said, “The EUA to CORBEVAXTM is yet another example of a successful academia-industry collaboration. This vaccine will sharpen the country’s efforts in ending the pandemic. The development of indigenous vaccines to fight the pandemic will also inspire the country’s scientists and manufacturers to resolve the problems of the country.”

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “We would like to take the opportunity to specially thank our Prime Minister Shri Narendra Modi for making vaccination a national mission. His vision and the advance commitments we received towards CORBEVAXTM were instrumental in our ability to scale-up and manufacture at such huge capacities. While COVID Suraksha Program’s endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was setup with the support of Department of Biotechnology and DBT-Biotechnology Industry Research Assistance Council (BIRAC) allowed us to scale up to a capacity of about 1.2 billion doses per annum making the dream of accessibility – affordability and supply – a reality.”