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Zydus Cadila seeks emergency use approval for its COVID-19 vaccine candidate

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In a significant development, Ahmedabad-based Zydus Cadila has sought emergency use approval for its three-dose COVID-19 vaccine candidate ‘ZyCoV-D’ from the Indian drug regulator. Notably, the company is claiming it to be the world’s first ‘plasmid DNA’ vaccine that is needle-free and safe for children.

A plasmid DNA vaccine, when injected, produces the spike protein of the coronavirus and incites an immune response. Plasmid DNA platforms can be quickly modified to deal with new mutations, the company said.

If the Drugs Controller General of India grants permission to the company, it will be the fifth COVID-19 vaccine to get emergency use clearance in India after Covishield, Covaxin, Sputnik-V, and Moderna. The company claimed that it will be able to manufacture up to 120 million doses of the vaccine a year.

66.6% efficacy

The vaccine candidate is 66.6 per cent effective in protecting against symptomatic COVID-19 cases and 100 per cent effective for moderate cases, the company claimed. It also claimed that the vaccine is safe for children between 12-18 years. However, the trial data is yet to be peer-reviewed.

The Phase 3 trials were carried out through the outbreak of Delta, the fast-spreading Covid variant first detected in India and believed to be driving new cases in parts of the world. The study was carried out “during the peak of 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.

Three doses required

Unlike the other two-dose vaccines already in circulation across the globe, the ZyCoV-D is a three dose vaccine that can be administered without a needle. The vaccine can be stored at 2 to 8 degrees Celsius and has also exhibited good stability at temperatures of 25 degrees Celsius for at least three months, the company claimed.

 

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