The country's first indigenous mRNA vaccine candidate, developed by Gennova, Pune, has received approval from drug regulators to initiate Phase 1/2 human clinical trials, the Department of Biotechnology said on Friday.
The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology.
The mRNA vaccines do not use the conventional model to produce immune response. Instead, they 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 recognised, thereby, making the body mount an immune response against the disease.
"Such vaccines are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.
Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria.
"Therefore, they can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their "availability" and "accessibility" for mass vaccination on a sustainable basis," said a statement by the DBT.
Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate. HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activity in animals, said the statement.