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Zydus applies for emergency use nod for Covid-19 vaccine - The Hindu BusinessLine

Zydus applies for emergency use nod for Covid-19 vaccine July 01, 2021 × Interim results from Phase III clinical trials demonstrate safety and efficacy for the 12-18 age group. Cadila Healthcare (Zydus Cadila) has applied for the Emergency Use Authorization (EUA) to the office of the Drug Controller General of India (DCGI) for its Plasmid DNA Vaccine for Covid-19 - ZyCoV-D, the company informed. The company has presented interim results from Phase III clinical trials in over 28,000 volunteers. It it claims to be the largest clinical trial for its Covid-19 vaccine far across over 50 centres in India. Once granted EUA, Zydus plans to manufacture 10-12 crore doses annually.

Zydus Cadila seeks approval for vaccine, says it works against Delta strain

In what could be the world’s first approved deoxyribonucleic acid (DNA)-plasmid vaccine, Ahmedabad-based Cadila Healthcare’s three-dose vaccine ZyCoV-D is expecting a nod from India’s drug regulator. The vaccine has shown 66.6 per cent efficacy in interim analysis of Phase 3 trials, and can be stored at 25 degrees Celsius for three months. No moderate case of Covid was observed in the vaccine arm after administration of the third dose, suggesting 100 per cent efficacy for moderate disease. No severe cases or deaths due to Covid occurred in the vaccine arm after administration of the second dose of the vaccine, the company claimed.

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