India's first indigenously-developed receptor binding domain (RBD) protein sub-unit COVID-19 vaccine, Corbevax, developed by Biological E Ltd, has received the Drug Controller General of India's approval for Emergency Use Authorization (EUA).

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The Department of Biotechnology and its public sector undertaking, the Biotechnology Industry Research Assistance Council (BIRAC), had supported Biological E's COVID-19 vaccine candidate from the pre-clinical stage through Phase 3 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. Corbevax is a two-dose vaccine administered intramuscularly and can be stored at 2 degrees Celsius to 8 degrees Celsius," a Science and Technology Ministry release said on 29 December.

The recombinant protein sub-unit vaccine developed from the RB of the spike protein on the viral surface is adjuvanted with Dynavax's CpG 1018 and alum. Comprehensive Phase 3 clinical trials involving more than 3,000 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 autonomous institute under the DBT, provided key immunogenicity data for the Phase 2/3 studies. "The EUA to Corbevax 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," the Secretary of Biotechnology said.

Biological E Ltd Managing Director Mahima Datla said: "The PM's vision and the advance commitments we received towards Corbevax were instrumental in our ability to scale-up and manufacture at such huge capacities. While COVID Suraksha Programme's endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was set up with the support of the Department of Biotechnology and DBT-BIRA) 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."