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COVID-19: Gennova Biopharmaceuticals gets conditional nod for human trials of its vaccine
New Delhi, Dec 10: 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.
Covaxin vaccine to be available in first quarter of next year: Bharat Biotech
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.
