Zydus Cadila to seek emergency use authorisation for COVID-19 vaccine in India

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.

Experts are saying that the children rarely develop severe forms of COVID-19 but the states of Maharashtra and Karnataka have recently seen a spike in paediatric cases, and some deaths as well.  In rare cases of COVID-19, paediatric black fungus have been reported too. In the US, Canada and the EU children of the age group 12-15 are already being jabbed, while the United Kingdom has also approved the Pfizer/BioNTech vaccine for that age group.

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