India’s First mRNA Candidate Vaccine Gets Regulator Clearance for Human Trials

The country’s first indigenous Covid-19 mRNA candidate vaccine has received approval from Indian drug regulators to initiate Phase I / II human clinical trials.

The mRNA candidate vaccine, HGCO19, has been developed by the Pune-based company Gennova and is supported by an initial grant from the Ind-CEPI mission of the Department of Biotechnology of the Ministry of Science and Technology.

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MRNA vaccines do not use the conventional model to produce an immune response. Instead, the mRNA vaccine carries the molecular instructions for making the protein in the body via synthetic RNA from the deadly virus.

The host organism uses this to produce the viral protein that is recognized and thus causes the organism to generate an immune response against the infection. MRNA-based vaccines are scientifically the ideal choice to deal with a pandemic due to their rapid development.

MRNA vaccine considered safe

The mRNA vaccine is considered safe as it is not infectious, is not naturally integrated, and is degraded by standard cellular mechanisms.

They are expected to be very effective due to their inherent ability to be translated into the protein structure within the cell cytoplasm.

Furthermore, mRNA vaccines are completely synthetic and do not require a host for growth, eg eggs or bacteria. Therefore, they can be quickly manufactured economically under cGMP conditions to ensure their “availability” and “accessibility” for mass vaccination in a sustainable way.

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

HGCO19 has already demonstrated safety, immunogenicity, and neutralizing antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable to sera from COVID-19 convalescent patients.

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

HGCO19 uses adsorption chemistry to make the mRNA adhere to the surface of the nano-lipid carrier to improve the release kinetics of the mRNA within cells compared to encapsulation chemistry.

HGCO19 is stable at 2-8 ° C for two months. Gennova has completed all preliminary work and will begin the phase I / II human clinical trial soon, as approval has been received from the DCGI office.

The Department of Biotechnology, Ministry of Science and Technology, Government of India is implementing the IndCEPI mission ‘India Centered Epidemic Preparedness through Rapid Vaccine Development: Supporting Vaccine Development in India’, which is aligned with CEPI’s Global Initiative and aims to strengthen the development of vaccines and associated competencies / technologies for diseases with epidemic potential in India. DBT’s Ind-CEPI mission is implemented by its PSU, the Biotechnology Industry Research Assistance Council (BIRAC).

“The establishment of such an indigenous technology platform will not only enable India to handle the COVID-19 pandemic, but will also ensure preparedness for future outbreaks,” said Dr. RenuSwarup, Secretary of the Department of Biotechnology and Chairman of BIRAC.

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