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Biological E. gets DCGI approval for phase III trial for its covid vaccine

Biological E. has received Drugs Controller General of India (DCGI) approval for conducting Phase III Comparator Safety and Immunogenicity trial in adults after Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data. Biological E. has 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. The candidate is a RBD protein sub-unit vaccine.

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. 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.

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. 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.

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC speaking on the subject said that “ 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 .” “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,’’ said Mahima Datla, Managing Director, Biological E. Limited. “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.

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