Genova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, on Wednesday announced that its mRNA vaccine Gemkovac-19 against Covid-19 has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI).
Gemcovac-19 is the first mRNA vaccine developed in India, and only the third mRNA vaccine in the world approved for COVID-19.
“These vaccines are highly efficacious because of their inherent ability to be translated into protein structures inside the cell membrane. mRNA vaccines are considered safe because the mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. is,” the company said in a statement.
Notably, this technology provides the flexibility to quickly change the vaccine for any existing or emerging variant of the virus and this technology platform will empower India to be pandemic prepared, it said.
Gemcovac-19 has reached the primary endpoint of a phase-3 clinical trial. “The clinical data was evaluated by the Central Drugs Standard Control Organization (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic,” the company said, adding that the firm aims to reach approximately 4–4 per month. 5 million doses are to be produced and this capacity can be quickly doubled.