Gennova's mRNA-based Covid vaccine gets nod for Phase 2/3 clinical trials

Gennova's mRNA-based Covid vaccine development programme was partly funded by the DBT under Ind CEPI in June 2020

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