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Speed Post News Network

New Delhi : India’s first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune, and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology of M/o Science & Technology.

The mRNA vaccine do not use the conventional model to produce immune response. Instead, mRNA vaccine carries 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 and thereby making the body mount an immune response against the disease.

mRNA-based vaccine are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. The mRNA vaccine is considered safe as it is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Additionally, mRNA vaccine 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.

Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate. HGCO19 has already demonstrated safety, immunogenicity, and neutralisation antibody activity in animals. The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19.

Gennova’s vaccine candidate uses the most prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which gives the advantage of a low dosing regimen compared with the non-replicating mRNA or traditional vaccine. HGCO19 uses the adsorption chemistry so that the mRNA is attached on the surface of the nano-lipid carrier to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry, according to a PIB release.