 "Gennova Biopharmaceuticals")
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.
"Gennova submitted the proposed Phase 2 and Phase 3 study entitled 'A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase 2 study
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