CORBEVAX, Biological E Limited’s first indigenously designed Receptor Binding Domain (RBD) protein subunit vaccine for COVID-19, has acquired Emergency Use Authorization from the Drug Controller General of India (DCGI) for the 12-18 year age range. It has been licensed for use in humans, including children and adults aged 12 and up.
From pre-clinical to Phase III clinical trials, the Department of Biotechnology (DBT) and its Public Sector Undertaking (PSU), the Biotechnology Industry Research Assistance Council (BIRAC), have backed Biological E’s COVID-19 vaccine candidate.
The vaccine candidate received funding for pre-clinical studies and Phase I/II clinical trials through the COVID-19 Research Consortium, which is funded by the National Biopharma Mission. Mission COVID Suraksha gave additional funding to help with clinical development. CORBEVAX is a two-dose intramuscular vaccine that can be stored at temperatures ranging from 2 to 8 degrees Celsius.
CORBEVAX was approved in December
The Receptor Biding Domain (RBD) of the spike protein on the viral surface is adjuvanted with CpG 1018 and alum in a recombinant protein subunit vaccine. On December 28, 2021, the Drug Controller General of India approved CORBEVAX for restricted usage in emergency situations among adults. Biological E has been approved for restricted use in an emergency circumstance in teenagers aged 12 to 18 years old based on interim results of the current phase II/III clinical research.
The vaccine is safe and immunogenic, according to the existing safety and immunogenicity results from the ongoing phase II/III clinical investigation. The immunogenicity data for the Phase II/ III investigations came from the Translational Health Science and Technology Institute (THSTI), a DBT Autonomous Institute.
“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,” said Dr. Rajesh Gokhale, Secretary, Department of Biotechnology, and Chairperson, BIRAC, Government of India. This is the second vaccine to gain EUA for the age group of 12-18 years under the Mission. Corbevax is based on a tried-and-true foundation, and it might be a crucial vaccine for India and the rest of the world. This is yet another example of a successful industry-academic collaboration.”
“We are happy with this important development, which helps our CORBEVAX accomplish yet another milestone in extending our COVID-19 immunization campaign to encompass the 12-18 age group,” stated Ms. Mahima Datla, Managing Director, Biological E. Limited. With this approval, we are one step closer to completing our global COVID-19 pandemic response. We appreciate the support we’ve received from the Indian government’s Department of Biotechnology (DBT), the Biotechnology Industry Research Assistance Council (BIRAC), the Translational Health Science and Technology Institute (THSTI), all of the clinical trial participants, and the principal investigators and clinical site staff over the last few months.”
DBT (Dialectical Behavior Therapy)
Under the Ministry of Science and Technology, the Department of Biotechnology (DBT) promotes and accelerates the development of biotechnology in India, including its growth and application in agriculture, healthcare, animal sciences, the environment, and industry.
BIRAC’s Background:
The Department of Biotechnology (DBT) of the Government of India established the Biotechnology Industry Research Assistance Council (BIRAC) as an Interface Agency to strengthen and empower the emerging biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.
About Biological E. Limited
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company formed in 1953, is India’s first private sector biological products company as well as Southern India’s first pharmaceutical company. BE is a company that creates, manufactures, and distributes vaccines and treatments. Biological E sells vaccinations in over 100 countries and medicinal treatments in India and the United States. BE’s vaccine portfolio now includes eight WHO-prequalified vaccinations.
BE has started on new organizational expansion projects in recent years, such as generating generic injectable pharmaceuticals for regulated markets, studying synthetic biology and metabolic engineering as a means of producing APIs sustainably, and developing innovative vaccines for the worldwide market.