India’s 1st mRNA vaccine candidate gets DCGI nod for human trials

India’s first indigenous mRNA vaccine candidate has received approval to initiate Phase 1 and 2 human clinical trials from Drugs Controller General of India (DCGI).

Pune-based Gennova Biopharmaceuticals developed the COVID-19 vaccine candidate, HGCO19, in collaboration with US-based HDT Bio. The vaccine demonstrated “safety and immunogenicity” in rodent and non-human primate models, Gennova said.

These mRNA vaccines carry the molecular instructions to make the protein in the body through a synthetic RNA of the virus. The host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease.

The vaccine, being developed by Pune-based Gennova Biopharmaceuticals, is stable at 2-8°C for two months.