The Drugs Controller General of India (DCGI) on Wednesday granted conditional permission for phases 1 and 2 human clinical trial of the COVID-19 vaccine candidate developed by the Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT, USA, officials said.
The recommendations of the Subject Expert Committee (SEC) on COVID-19, which deliberated upon the proposal submitted by the firm for grant of permission to conduct phases 1 and 2 clinical trials along with animal toxicity study data, has been approved by DCGI.
"After detailed deliberation, the committee recommended for grant of permission to conduct phase 1 and 2 clinical trial subject to the condition that the interim results of phase 1 study shall be submitted to the committee before proceeding to the next phase," the SEC recommendations stated.
The Department of Biotechnology had earlier said it has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for COVID-19.
In collaboration with HDT Biotech Corporation, USA, Gennova has developed an mRNA vaccine candidate (HGCO19), with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models, it had said.
"DBT-BIRAC has facilitated the establishment of the first-of-its-kind mRNA-based vaccine manufacturing platform in India. DBT has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for COVID-19, the DBT had said in a statement earlier.
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