India’s First Indigenous mRNA COVID-19 Vaccine Gets DCGI Nod For Human Trial

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

India’s first indigenous COVID-19 mRNA vaccine candidate gets approval from the Drug Controller General of India to initiate Phase I/II human clinical test, the Ministry of Earth Sciences said on Friday.

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

It is Easy To Develop And Store

The conventional model to supply immune reaction isn’t employed by the mRNA vaccines. Instead, it carries the molecular instructions to form the protein within the body through an artificial RNA of the virus. The host body uses this to supply the viral protein that’s known and thereby making the body build an immune reaction against the disease.

The mRNA-based vaccines are scientifically the perfect option to address an epidemic due to their rapid developmental timeline. They will also not be degraded by standard cellular mechanisms and that they considered to be safe because they’re non-infectious and non-integrating in nature.

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MRNA Vaccines Are Cost Effective

The mRNA-based vaccines are expected to be highly efficacious due to their inbuilt capability of being translatable into the protein structure inside the cell cytoplasm.
As well as, these are fully synthetic and don’t require a number for growth, e.g., eggs or bacteria. Therefore, they will be quickly manufactured in a cheap manner under cGMP conditions to make sure their “availability” and “accessibility” for mass vaccination on a sustainable basis.

Animal Trials Show Safety and Efficacy

Gennova, in association with HDT Biotech Corporation, Seattle, USA, has developed this vaccine candidate called HGCO19. It has been found to be safe in immunogenicity, neutralization antibody activity in animals.

The neutralising antibody response of the vaccine in mice and non-human primates was comparable the sera from the convalescent patients of COVID-19.

Gennova’s vaccine candidate uses the foremost prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which provides the advantage of a coffee dosing regimen compared to a non-replicating mRNA or traditional vaccines.

HGCO19 uses the adsorption chemistry in order that the mRNA is attached on the surface of the nano-lipid carrier to reinforce the discharge kinetics of the mRNA within the cells compared to the encapsulation chemistry.

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Human Trials to start out Soon

This vaccine is stable at 2-8 degrees Celsius for 2 months. Gennova has completed all preliminary work and will be initiating the Phase I/II Human clinical test soon since the approval from the DCGI office has been received.

The Department of Biotechnology is implementing the IndCEPImission ‘India Centric Epidemic Preparedness through Rapid Vaccine Development: Supporting Indian Vaccine Development’ which is aligned with the worldwide Initiative of CEPIand aims to strengthen the event of vaccines and associated technologies for the diseases of epidemic potential in India.

The Ind-CEPI mission of DBT is implemented by its PSU, Biotechnology Industry Research Assistance Council ( BIRAC).

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

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