India’s first mRNA vaccine from Gennova gets DCGI approval

India’s first mRNA vaccine from Gennova gets DCGI approval

• India’s first mRNA vaccine against the COVID-19 gets the Emergency Use Authorization (EUA), to be sold under the brand name GEMCOVAC™-19.

· The vaccine will be available for adults above 18 years of age.

· It is a two dose vaccine to be administered intramuscularly at 28 days apart.

Pune, India, June 29, 2022: 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).

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. 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.

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

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 pandemic.