Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd., said its mRNA vaccine – GEMCOVAC™-19 – against Covid‑19, has received Emergency Use Authorisation (EUA) from the office of the Drugs Controller General of India (DCGI).

The press statement from the company said GEMCOVAC-19™ is the first mRNA vaccine to be developed in India, and only the third mRNA vaccine to be approved for Covid-19 globally.

“These vaccines are highly efficacious because of their inherent capacity to be translated into the protein structure in the cell cytoplasm. mRNA vaccines are considered safe as they are non-infectious, non-integrating in nature, and are degraded by standard cellular mechanisms. Notably, this technology provides the flexibility to tweak the vaccine for any existing or emerging variants of the virus, and this technology platform will empower India to be pandemic ready,” the press statement added.

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

Gennova Biopharmaceuticals Ltd aims to produce 40-50 lakh doses per month and this capacity could be quickly doubled.

Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries to rein in the spread of the pandemic.

Gennova Biopharmaceuticals Ltd., headquartered in Pune, is engaged in research and development, production, and commercialisation of biotherapeutics (biologics and vaccines) to address life-threatening diseases across indications.

Related Topics