Gennova Biopharmaceuticals Ltd’s mRNA-based COVID-19 vaccine candidate HGCO19, India’s first, has received approval to conduct phase 2/3 clinical trials, stated the Department of Biotechnology (DBT).

The company had submitted interim phase 1 study clinical data to the Central Drugs Standard Control Organisation. The vaccine subject expert committee, on reviewing the data, noted that the vaccine candidate was safe, tolerable, and immunogenic in study participants.

The study is now going to be carried out at around 10-15 sites in phase 2 and 22-27 sites in phase 3. The company intends to use the DBT-ICMR clinical trial network sites for the study. The Department of Biotechnology has partly funded Gennova’s mRNA-based COVID-19 vaccine development program… (ET Healthworld – PTI, August 25, 2021)