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  • Gennova Biopharma wins...

Gennova Biopharma wins DCGI conditional nod for human clinical trial of Covid-19 vaccine

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-12-11T18:49:34+05:30  |  Updated On 11 Dec 2020 6:49 PM IST
Gennova Biopharma wins DCGI conditional nod for human clinical trial of Covid-19 vaccine
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The recommendations of the Subject Expert Committee (SEC) on Covid19, 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.

New Delhi: The Drugs Controller General of India (DCGI) on Wednesday granted conditional permission for phases 1 and 2 human clinical trials 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.
Read also:COVID-19: Envoys of 64 countries visit vaccine maker Bharat Biotech, Biological E in Hyderabad
"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.

Read also: Three COVID vaccines under active consideration of drug regulator: Health Ministry

gennova biopharmagennova biopharma newscoronavirus vaccinecovid-19coronavirusdcgihgco19
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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