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Covid: Local mRNA vaccine gets nod for human trials – Times of India

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NEW DELHI: The drug regulator has allowed human trials of the first local mRNA Covid vaccine candidate and the preliminary results are likely by March. It assumes significance as Covid-19 vaccines based on this platform, such as those by Pfizer-BioNtech and Moderna, are expected to have better efficacy but currently appear out of bounds for India.
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) that met on Wednesday recommended grant of conditional approval for phases 1/2 human clinical trial of the vaccine candidate. The recommendations of the panel were later approved by the Drugs Controller General of India (DCGI).
Pune-based Gennova Biophar maceuticals has developed the vaccine candidate in collaboration with Seattle-based HDT Biotech Corporation.
“After detailed deliberations, the committee recommended for grant of permission to conduct phase 1 and 2 clinical trials subject to the condition that the interim results of phase 1 study shall be submitted before proceeding to the next phase,” the SEC said.
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. Experts said such vaccines can also be manufactured faster in an inexpensive manner and can, therefore, help to ensure availability for mass vaccination on a sustainable basis.

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