Pune, Genoa Bio Pharmaceuticals Limited, a subsidiary of Amcure Pharmaceuticals Limited, has announced that its mRNA vaccine against Covid-19 – GEMCOVAC-19 has received Emergency Use Authorization from the Office of the Controller General of Drugs (DGCI).
The GEMCOVAC-19 vaccine is the first mRNA vaccine to be developed in India and will be only the third mRNA vaccine to be approved for COVID-19 in the world.
These vaccines are very effective, due to their genetic ability to alter the structure of proteins within the cell cytoplasm.
mRNA vaccines are considered safe because mRNA is non-infectious, non-integrating, and degraded by standard cellular systems.
Significantly, this technology facilitates rapid replacement of the vaccine for any existing or evolving variant of the virus, and this technology platform equips India for an epidemic.
GEMCOVAC of GenoaClinical testing of -19 has reached the main end point of the third phase. Clinical data were evaluated by the Central Drugs Standards Control Organization (CDSCO). The vaccine was reported to be safe, well tolerated and immune.
Genova Biopharmaceuticals Ltd. aims to produce about 40 to 50 million doses per month and this capacity could be doubled rapidly.
Genoa aims to provide vaccine access to low- and middle-income countries around the world, in addition to India, to prevent the spread of the epidemic.