Department of biotech companies Mission COVID Suraksha

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

India’s first indigenously developed Receptor Binding Domain (RBD) protein subunit vaccine for COVID-19, CORBEVAXTM, developed by biotech companies E Limited, has received the Drug Controller General of India (DCGI) approval for Emergency Use Authorization (EUA).
Department of biotech companies Mission COVID Suraksha
Department of biotech companies Mission COVID Suraksha

The Department of biotech companies (DBT) and it's 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 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 subunit vaccine developed from the Receptor Binding 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 Autonomous Institute of DBT, provided key immunogenicity data for the Phase II/ III studies.

The EUA to CORBEVAXTM biotech companies

Dr. Rajesh Gokhale, Secretary, Department of biotech companies, 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 especially 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 endeavor to accelerate vaccine development played a crucial role in the initial development, the mechanism was set up with the support of the Department of Biotechnology. 

And The DBT-Biotechnology (biotech companies) 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.”

About DBT

The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes and accelerates the development of biotechnology in India, including growth and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment, and industry.

About BIRAC: biotech companies

Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by the Department of Biotechnology (DBT). 

Government of India as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.


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 vaccines 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 vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing generic injectable products for the regulated markets. 

The exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably, and develop novel vaccines for the global market.   


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