New Delhi: Human trials for India’s first mRNA (messenger RNA) vaccine will begin next month and is expected to be effective against Omicron, the highly-transmissible variant of coronavirus which is driving the third wave of COVID-19 pandemic in India.
Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of the mRNA vaccine and completed recruitment for phase III data, ANI reported.
The Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) is l
ikely to review the data soon, ANI added.
DCGI had approved phase 2 and 3 study protocols for India’s first mRNA-based COVID-19 vaccine, developed by Gennova Biopharmaceuticals Limited, in August 2021.
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Early studies found the vaccine, named HGCO19, to be “safe, tolerable, and immunogenic” in the participants of phase 1 trial.
The pharmaceuticals company said that the study for mRNA vaccine, which is now being developed for Omicron variant also, is being conducted in India at 10-15 sites in phase 2 and 22-27 sites in phase 3.
In developing mRNA vaccines, genetic material from disease-causing viruses or pathogens are used to trigger an immune response against it within the body.