India may soon get its first indigenous mRNA or messenger RNA COVID-19 vaccine as Gennova Biopharmaceuticals Ltd is looking to start the first phase of human trials for its vaccine this month.
The Pune-headquartered company, a subsidiary of Emcure Pharmaceuticals, had received approval in December last year to start phase 1 and 2 trials for its COVID-19 vaccine candidate. However, it got delayed as the Drugs Controller General of India (DGCI) asked the company to repeat the animal toxicity study which it had conducted in the US.
"The DCGI cleared it in December, but we had originally submitted our pre-human animal toxicity studies from the work we had done in the US. mRNA is a brand-new technology and there's no commercial mRNA product in India. There were certain protocols and formalities to be followed, wherein they wanted us to repeat the animal toxicity studies in the Indian setting," Mint quoted Vikas Thapar, president of corporate development and strategy at Emcure Pharmaceuticals, as saying.
A mRNA vaccine carries molecular instructions through a synthetic RNA of the virus to make the protein that triggers an immune response in the body. The COVID-19 vaccines of Pfizer and Moderna are based on this technology.
Gennova Biopharma expects to begin the second phase of human trials after two months from the start of first phase. It will seek emergency use approval from DGCI if phase 2 trial is successful, Thapar said.
It will later also look at partnering other companies to scale up production of the vaccine and ingredients used in it. It also plans to produce some of the raw materials needed for the vaccine itself.
Gennova Biopharma's vaccine candidate can be stored at 2-8 degree Celsius temperature, unlike Pfizer and Moderna vaccines which require ultra-low temperatures.