India’s 1st indigenously developed mRNA vax against Covid gets DCGI approval

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The apex drug regulator Drugs Controller General of India (DCGI) has approved India’s first indigenously developed mRNA vaccine against Covid-19. The vaccine has been given approval for restricted emergency use for those aged 18 years and above.

“Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd., announced that its mRNA vaccine — GEMCOVAC-19 — against Covid-19 received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI),” said a statement from the vaccine manufacturer Gennova Biopharmaceuticals on Wednesday.

It is a two dose vaccine to be administered intramuscularly at 28 days apart. The vaccine will be sold under the brand name GEMCOVAC-19.

GEMCOVAC-19 is the very first mRNA vaccine developed in India and only third mRNA vaccine to be approved for Covid-19 in the world.

“These vaccines are highly efficacious because of their inherent capacity of being translated into the protein structure inside the cell cytoplasm. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms”, said the vaccine manufacturer.

This technology provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus and this technology platform will empower India to be pandemic ready.

The Pune-based manufacturer said that the clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic.

The company claimed that it aims to produce around 40 – 50 lakhs of doses per month and this capacity can be quickly doubled.

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