India’s first homegrown mRNA vaccine to be tested amid Omicron spike: Official sources | India News – Times of India

New Delhi: The country’s first messenger MRNA vaccine is expected to be tested on humans in February.
Pune-based Genova Biopharmaceuticals has submitted Phase 2 data for the MRNA vaccine and has also completed the recruitment of Phase 3 data. The Committee of Experts on Drugs Controller General (DCGI) of India (SEC) is expected to review the data soon, official sources said.
Genova Biopharmaceuticals has also developed an mRNA vaccine for the Omicron variant that will soon be tested on humans for efficacy and immunogenicity, official sources said.
In early September 2021, Genova issued a press release and updated on the trial of the vaccine. Created in August by Biopharmaceuticals Limited (“Gennova”). ”
“Intermediate clinical data from the first phase of the Genoa study have been submitted to the Central Drugs Standards Control Organization (CDSCO), the Government of India’s National Regulatory Authority (NRA). It was safe, tolerable and immunogenic, “she says
The company also mentioned the number of trial sites, “Research is being conducted on about 10-15 sites in India in the second phase and 22-27 sites in the third phase. Genova is using DBT-ICMR clinical trial network sites for this research.”
The mRNA vaccines belong to the category of nucleic acid vaccines, which use genetic material from a pathogenic virus or pathogen to build resistance in the body against it.

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