'Made in India' Covid vaccine gets nod for human clinical trial
First Published Dec 11, 2020, 7:45 PM IST
India's first indigenous mRNA vaccine candidate has received approval from the Drugs Controller General of India to initiate Phase I/II human clinical trial.
The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology of Science & Technology ministry.
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.
Two other vaccines -- Covishield and Covaxin -- are in the third stage of clinical trials and have parallely applied for emergency use authorisation to the DCGI.
What are mRNA vaccines?
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.
mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline.
mRNA vaccines are considered safe
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.
Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., 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.
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