The Central Drugs Standard Control Organisation (CDSCO), India's National Regulatory Authority, has approved Gennova Biopharmaceuticals Limited's work on the country's first mRNA-based COVID-19 vaccine for its clinical data of the phase-1 study.
"Vaccine Subject Expert Committee (SEC) reviewed the interim phase-1 data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study. The Director General (I), CDSCO, approved the proposal submitted for the phase 2 and 3 studies by Gennova Biopharmaceuticals Limited, a Pune-based biotechnology company," the Ministry of Science and Technology said in a release on Tuesday.