mRNA Vaccine For Omicron Variant Trial To Begin From February

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Human trials of mRNA vaccine against COVID-19’s new variant Omicron is to begin from February, 2022.

Notably, Pune-based Gennova Biopharmaceutical made mRNA vaccine and completed phase I and II trials and submitted a report to the Drugs Controller General of India (DCGI).  Along with it, the company also submitted a data of Phase III trials and are waiting for their approval from the Vaccine Subject Expert Committee (SEC).

Earlier in the month of September 2021, the Gennova issued a press statement and updated about the vaccines trials, “The Drug Controller General of India, had approved the Phase II and Phase III study protocols for HGCO19, India’s first mRNA-based Covid-19 vaccine, developed by Gennova Biopharmaceuticals Limited (“Gennova”) back in August.”

The Government of India’s National Regulatory Authority said, “Gennova had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO).  The Vaccine Subject Expert Committee (SEC) had reviewed the interim Phase I data, and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.”

mRNA vaccines belong to the category of nucleic acid vaccines, which use genetic material from disease-causing virus or pathogen to trigger an immune response against it within the body.

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