3rd mRNA Vaccine Authorized for Adults

India-based Gennova Biopharmaceuticals Ltd. announced today that its GEMCOVAC™-19 mRNA vaccine received the Emergency Use Authorization from the office of the Drugs Controller General of India.

GEMCOVAC-19 is the first mRNA vaccine developed in India and the only third mRNA vaccine approved for COVID-19 worldwide.

The U.S. FDA has already approved two mRNA vaccines for infants, adolescents, and adults.

GEMCOVAC-19 had reached the primary endpoint of the Phase III clinical trial, and the Central Drugs Standard Control Organisation evaluated the data.

The vaccine was found to be safe, well-tolerated, and immunogenic.

In addition, mRNA vaccines are considered safe as they are deemed 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 virus variants, and this technology platform will empower India to be pandemic ready, says Gennova.

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

Beyond India, Gennova aims to provide sustainable access to low-and middle-income countries.

Gennova, headquartered in Pune, India, is a biotechnology company dedicated to developing, producing, and commercializing biotherapeutics to address life-threatening diseases across various indications.

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