India’s first indigenous mRNA vaccine developed by Gennova, Pune has received approval from Indian drug regulators to initiate Phase 1/II human clinical trials. 

 

The mRNA vaccine HGCO19 has been developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology of Ministry of Science & Technology.

 

The mRNA vaccines 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 recognized and thereby making the body mount an immune response against the disease. 

 

The 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. They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. 

 

Gennova in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine. 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. 

 

HGCO19 is stable at 2-8°C for two months. Gennova has completed all preliminary work and should be initiating the Phase I/II human clinical trial soon since the approval from the DCGI office has been received.

 

Establishment of a such indigenous technology platform will not only empower India to handle the COVID-19 pandemic but also ensure the preparedness for future outbreaks,’ said Dr. Renu Swarup, Secretary, Department of Biotechnology and Chairperson of BIRAC.