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Zydus Cadila seeks DCGI s Emergency Use Authorization for ZyCoV-D

Zydus Cadila today announced that the company has applied for Emergency Use Authorization (EUA) to the office of Drug Controller General of India (DCGI) for ZyCoV-D - its Plasmid DNA Vaccine against COVID-19. The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centers. This was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age group in India. Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population. Primary efficacy of 66.6% has been attained for symptomatic RT-PCR positive cases in the interim analysis.

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.

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