Gennova’s mRNA-based COVID-19 vaccine gets approval for Phase 2/3 clinical trials
The Hindu
The study will be conducted in the country at approximately 10-15 sites in Phase 2 and 22-27 sites in Phase 3.
India’s first mRNA-based COVID-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for Phase 2/3 clinical trails, the Department of Biotechnology (DBT) said on Tuesday. The Pune-based biotechnology company had submitted the interim clinical data of the vaccine’s Phase 1 study to the Central Drugs Standard Control Organisation (CDSCO), it said. The Vaccine Subject Expert Committee (SEC) reviewed the interim Phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in the participants of the study.
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