Pune's Gennova gets nod for clinical trials of India's first mRNA vaccine

DCGI granted conditional approval for phase 1 and 2 clinical trials of Gennova's mRNA based Covid-19 vaccine candidate

Pune based firm Gennova Biopharmaceuticals Ltd has been granted permission for phase 1 and 2 human clinical trials for the Covid-19 vaccine candidate developed by them. This would be the first Indian mRNA vaccine candidate.

The Drugs Controller General of India (DCGI) on Wednesday granted conditional permission for phases 1 and 2 human clinical trial of the Covid-19 vaccine developed by them. The Subject Expert Committee (SEC) deliberated on their proposal and granted permission to conduct phase 1 and 2 trials along with animal toxicity study data. DCGI has approved the same.

Meeting minutes of the SEC noted that, "After detailed deliberation, the committee recommended for grant of permission to conduct phase 1 and 2 clinical trial subject to the condition that the interim results of phase 1 study shall be submitted to the committee before proceeding to the next phase."

Gennova has developed the vaccine in collaboration with HDT, USA while the Department of Biotechnology had provided seed funding for the development of the mRNA technology based candidate named HGCO19.