Biological E’s Corbevax gets DGCI approval for two clinical trials

at 3:51 pm
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New Delhi: The Drugs Controller General of India (DCGI) has given approval to Biological E to conduct phase 2 and 3 clinical trials of its CORBAVEX Covid vaccine, the Ministry of Science and Technology said today.

Biological E, the Hyderabad-based pharmaceutical company received approval for Phase III Comparator Safety & Immunogenicity trial in adults after Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data, the Ministry said in a statement.

Additionally, it had also received approval on September 1 to initiate the Phase II/III study to evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX™ vaccine in Children and Adolescents, it said.

CORBEVAX is an RBD protein subunit vaccine. The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E’s COVID-19 Vaccine candidate from Preclinical Stage to Phase III clinical studies, the Ministry said.

“Department through Mission COVID Suraksha launched under Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is committed to development of safe and efficacious COVID-19 vaccines. We look forward to the clinical development of candidate CORBEVAX™ for paediatric and adults,” Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said.

Managing Director, Biological E. Limited Ms Mahima Datla said, “We are delighted to receive these significant approvals from the DCGI.  These approvals encourage our organisation to move forward and successfully produce our COVID-19 vaccine to meet the vaccination needs.”

“We are grateful to BIRAC for their support and we are enthused that these approvals would help support our subsequent filings with WHO as well. We appreciate and acknowledge the contribution of all our collaborators for their continued support in this endeavour,” she further added.

In addition to receiving financial assistance under Mission COVID Suraksha, this vaccine candidate has also obtained a financial support under COVID-19 Research Consortia through National Biopharma Mission, BIRAC.

The Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India (GoI) has taken myriads of initiatives to increase investments in research & development (R&D) and manufacturing of COVID-19 Vaccines.

The establishment of Mission COVID Suraksha Program is one such endeavour for COVID-19 vaccine development to reinforce and streamline available resources towards a warpath for accelerated vaccine development, leading to bring in a safe, efficacious, affordable and accessible COVID-19 Vaccine for the citizens at the earliest with a target of Atmanirbhar Bharat.