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India’s first indigenous mRNA vaccine candidate receives approval to initiate Phase 1 and 2 human clinical trials

India’s first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate Phase one and two human clinical trials. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune and 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. mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.

Scientists say, these vaccines 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, neutralization antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19.

AIR correspondent reports that the Department of Biotechnology, Ministry of Science and Technology  is implementing the Ind-CEPI mission-India Centric Epidemic Preparedness through Rapid Vaccine Development and Supporting Indian Vaccine Development which is aligned with the Global Initiative of CEPI.

 

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