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 likely 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.
