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India’s first mRNA vaccine gets DCGI approval

Gennova Biopharmaceuticals Ltd. aims to produce around 40 - 50 lakhs of doses per month and this capacity can be quickly doubled.

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Pune: Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd., has 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).

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

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mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. Notably, 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, a company statement said.

Gennova’s GEMCOVAC™-19 has reached the primary endpoint of Phase III clinical trial. The clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated, and immunogenic, the statement said.

Gennova Biopharmaceuticals Ltd. aims to produce around 40 – 50 lakhs of doses per month and this capacity can be quickly doubled.

Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of the pandemic, it added.

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