Zydus Cadila may soon seek emergency use authorization for its vaccine from the Drug Controller General of India for children in the age group of 12-18.
Reports suggest that sources in the government and the company confirmed that the Ahmedabad-based firm may seek an emergency use authorization from the drug regulator in around a week.
If approved, this would be the first DNA-plasmid vaccine in the world.
“The data analysis from the phase 3 trials is almost ready. The company may soon seek EUA for its vaccine,” a government official was quoted as saying.
According to the report, ZyCov-D, developed by Ahmedabad-based Zydus-Cadila, uses plasmid DNA (in contrast to mRNA as used by Pfizer-BioNTech and Moderna) to instruct human cells to make SARS-CoV-2 antigen eliciting an immune response.
Therefore, it can be stored between 2-8 degrees Celsius, whereas the Pfizer-BioNTech vaccine requires cold-chain maintenance of up to -70 degrees Celsius, or at least -15 to -25 degrees Celsius. It is expected that the vaccine can be more easily “tweaked” than mRNA vaccines for use against variants.