India’s first mRNA vaccine receives approval for clinical trials

New Delhi, Dec 9 : The Central Drugs Standard Control Organisation on Wednesday permitted Pune-based Gennova Biopharmaceuticals to conduct Phase 1/2 clinical trials, along with animal toxicity data, for its mRNA Covid-19 vaccine candidate.
It is India’s first messenger RNA (mRNA) Covid vaccine candidate. Globally, US-based pharma giant Pfizer Inc has developed its mRNA vaccine.
The permission was granted after the Subject expert Committee (SEC) for vaccines recommended for grant of permission in a review meeting on Wednesday, a document carrying the recommendations and accessed by IANS showed.
“After detailed deliberation, the committee recommended for grant of permission to conduct Phase 1/2 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,” the document read.
The Department of Biotechnology had earlier said it has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for Covid-19.
Gennova has developed its mRNA vaccine candidate (HGCO19) in collaboration with HDT Biotech Corporation, US. The firm earlier said that the vaccine demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models.