India's 1st mRNA vaccine candidate gets regulator nod for human trials

New Delhi: In a major development, the apex drug regulator has approved the country's first indigenous mRNA Covid-19 vaccine candidate to initiate Phase I/II human clinical trials.

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

The mRNA vaccines do not use the conventional model to produce an immune response as the mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the deadly virus.

The host body uses this to produce the viral protein that is recognised and thereby making the body mount an immune response against the infection. 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 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, eg, 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.

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

"HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in animals. The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19," it said.

Commenting on the development, Department of Biotechnology Secretary and Chairperson BIRAC Dr Renu Swarup said, "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."

Swarup further added that HGCO19 is stable at 2-8°C for two months and Gennova has completed all preliminary work and should be initiating the Phase I/II Human clinical trial soon.