New Delhi: The Drug Controller General of India on Tuesday approved the emergency use of the indigenous mRNA COVID-19 vaccine developed by Genova Biopharma for individuals 18 years and above.
The approval came weeks after the DRS had pulled up the company for changing trial protocols without informing DCGI. Genova Biopharmaceuticals had submitted its final vaccine trial data to the Drugs Controller General of India (DCGI) for evaluation in March.
The Pune-based mRNA vaccine is to be stored at temperatures between 2-8 degrees whereas several others need to be stored at sub-zero temperatures.
The SEC in a meeting on Friday had recommended the EUA of the vaccine. The committee under the Drug regulator data underscored the documents submitted by Genova were satisfactory.
The pharma company has conducted phase 2 and phase 3 trials on 4000 participants to evaluate vaccine safety, immunogenicity and tolerability. This is the first homegrown vaccine paving the way a game changes in the health care industry.