Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, has received emergency use authorisation (EUA) from the office of the Drugs Controller General of India (DCGI) to market India's first mRNA vaccine against COVID-19.
Branded as 'GEMCOVAC-19', this will be the third m-RNA vaccine to be approved for COVID-19 in the world, after those developed by the U.S. companies Pfizer-BioNTech and Moderna.
Gennova Biopharmaceuticals says the company aims to produce around 40-50 lakh doses per month and this capacity can be quickly doubled. Beyond India, the company aims at providing sustainable access to low-and middle-income countries around the world. The vaccine will be available for adults above 18 years of age and will be a two-dose vaccine, which will be administered intramuscularly at 28 days apart.
Earlier, India had approved Covid-19 vaccines like Bharat Biotech's Covaxin, Serum Institute's Covishield and Covovax, Zydus Cadila's ZyCoV-D and Biological E's Corbevax.
"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," says the company.
Unlike traditional biotech vaccines like Covaxin and Covishield, the m-RNA technology was used for the first time to develop a vaccine during Covid, and was made successful by Pfizer-BioNTech combine and Moderna.
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," says Gennova.
Gennova is dedicated to research and development, production, and commercialisation of biotherapeutics (biologics and vaccines). It has commercialised seven products that include five biosimilars or off-patent biotech drugs, including a pioneering 'first-in-the-world' product.