New Delhi: India’s first mRNA-based vaccine candidate is now set to begin human trials. vaccine candidate. The vaccine which has been developed by Pune-based pharma company Gennova in collaboration with HDT Biotech Corporation, Seattle, USA, has received approval from drug regulators to initiate Phase 1/2 human clinical trials.

"Establishment of such indigenous technology platform will not only empower India to handle the COVID-19 pandemic but also ensure the preparedness for future outbreaks," Renu Swarup, Secretary, Department of Biotechnology said in a report by PTI.

The vaccine candidate named HGCO19 uses a mutant of spike protein (D614G) of the virus which interacts with the host cell receptor and a self-amplifying mRNA platform. The company said in a statement that the vaccine has shown safety, immunogenicity, neutralisation antibody activity.

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What is an mRNA vaccine?

Usually, in a vaccine, a weakened or inactivated pathogen is used to generate an immune response. The body creates antibodies as it tries to fight the germ. But an mRNA or messenger RNA vaccine teaches the body to make a protein. It gives instructions on how to make the protein and that generates the immune response. This helps in creating antibodies that protect us from the pathogen.

The mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. It is also 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 vaccines are fully synthetic and do not require a host for growth, for example, 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," the company said ina statement.

The company has said that it will soon start the animal toxicity studies in India, post which the clinical study design will be finalized.

India is also developing another Covid-19 vaccine, Covaxin. Last week, the Hyderabad based pharmaceutical firm, Bharat Biotech has sought emergency authorization of the vaccine.