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India gives permission for human trials of 1st mRNA vaccine

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Sushmi Dey    12 December 2020

The drug regulator has given permission to the human trials of the first local mRNA COVID vaccine candidate and the primary results are expected in March.

It is as sumingimplication as COVID-19 vaccines based on this platform, such as by Pfizer-BioNtech and Moderna, are projected to have better efficacy but appear off limits for India currently. The Subject Expert Committee that is under the Central Drugs Standard Control Organisation met on Wednesday and had recommended the grant of conditional approval for phases 1 and 2 human clinical trial of the vaccine candidate. Later, the recommendations of the panel were approved by the DCGI. Gennova Biopharmaceuticals, which is Pune-based, has developed the vaccine candidate in association with Seattle-based HDT Biotech Corporation.

The mRNA vaccines do not use the conventional model for producing immune response. They carry the instructions of molecules to produce protein in the body via a synthetic RNA of virus. The host body then uses it to produce the viral protein, which is recognized and thus makes the body stand an immune response against the disease. Scientifically, mRNA-based vaccines are the ideal choice to handle a pandemic due to their rapid developmental timeline.

The department of biotechnology said that the mRNA vaccine is generally considered safe as it is non-integrating in nature, non-infectious and degraded by cellular mechanisms that are standard.

Source: ET Healthworld

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