Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd. on Wednesday 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).
On Tuesday, DCGI approved India’s first home-grown mRNA Covid-19 vaccine by Gennova Biopharma for emergency use in 18 years and above. According to reports, while other mRNA vaccines require to be stored at sub-zero temperatures, Gennova’s mRNA vaccine can be stored at 2-8 degrees.
Developed in India, GEMCOVAC-19™ is the very first mRNA vaccine and the third mRNA vaccine to be approved for COVID-19 in the world. According to experts, mRNA vaccines are highly efficacious due to their inherent capacity of being translated into the protein structure inside the cell cytoplasm. Moreover, the technology provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus.
Meanwhile, 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 company claims.
Gennova Biopharmaceuticals Ltd. is planning 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 stated.
Last week, the Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for the mRNA vaccine against COVID-19.