Phase II/III paediatric trials will be conducted in children and adolescents
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 financial support under COVID-19 Research Consortia through National Biopharma Mission, BIRAC.
Biological E has received Drugs Controller General of India (DCGI) approval for conducting Phase III Comparator Safety & Immunogenicity trial in adults after Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data. Additionally, Biological E also received approval on September 1, 2021, to initiate the Phase II/III Study to evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the CORBEVAX vaccine in children and adolescents. The candidate is an RBD protein subunit vaccine.
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 the 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, MD, Biological E.
“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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