ZyCoVD
Zydus Cadila seeks DCGI's emergency use approval for its 3-dose, 'needle free' vaccine : Reports
New Delhi/IBNS: Gujarat-based pharma company Zydus Cadila has sought Drugs Controller General of India's (DCGI) approval for emergency use of its ZyCoV-D three-dose Covid shot which is the "world's first Plasmid DNA vaccine" and safe for children above the age of 12, according to media reports.
According to Reuters, the company has provided the interim results from phase III clinical trials that involved over 28,000 volunteers, across the country, including about 1,000 subjects in the 12-18 year age group, Zydus says.
The study was carried out "during the peak of the second wave of COVID-19 (in India), reaffirming the vaccine's efficacy against the new mutant strains, especially the Delta variant," Zydus said in a statement to the stock exchanges, according to Reuters.
The company claims 66.6 per cent efficacy of the vaccine against symptomatic Covid cases and 100 per cent for moderate infections.
The vaccine was found to be safe for children between 12 and 18 years but its trial data is awaiting peer-review.
The vaccine is ideally stored at 2 to 8 degree Celsius but has shown good stability at temperatures of 25degrees for at least three months, says the company, easing difficulties faced in transporting and storing coronavirus vaccines and also reduces any cold chain breakdown challenges.
"Also, being a plasmid DNA vaccine, ZyCoV-D doesn't have any problem associated with vector based immunity," the company says in a statement.
A plasmid DNA vaccine works by producing the spike protein of the coronavirus and subsequently inciting an immune response, Zydus says, adding thatifications can be made to the plasmid DNA platforms to deal with new mutations.
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