Zydus Cadila seeks Phase 3 vaccine trial nod; says 'ZyCoV-D is safe & immunogenic'

Indian pharmaceutical firm Zydus Cadila on Thursday said that its COVID-19 vaccine 'ZyCoV-D', has been found to be safe and immunogenic in Phase I and II clinical trials and is now seeking regulatory approval to commence Phase- III trials. Zydus Cadila said, "the company's plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe, well-tolerated and immunogenic in the Phase I/II clinical trials. The company is now planning to initiate Phase III clinical trials in around 30,000 volunteers upon receiving necessary approvals."

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Zydus Cadila seeks approval for Phase 3 clinical trials

Stating that the Phase II study of the vaccine, ZyCoV-D, had been conducted over 1,000 healthy adult volunteers as part of the adaptive Phase I and II, the company's statement said that the trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome. 

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Zydus Cadila said, "With ZyCoV-D, the company has established the DNA vaccine platform in the country. The platform is also known to show much-improved vaccine stability, thus requiring lower cold chain requirements. This makes the vaccine ideal for access in remotest regions of the country. The platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection."

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On the development, Zydus Cadila Group Chairman Pankaj R Patel said that after establishing safety in Phase I clinical trial, ZyCoV-D has now completed Phase II clinical trials and the COVID-19 vaccine has been found safe and immunogenic. He added, "We are optimistic of Phase III clinical trial outcomes as well and that we would be able to start the production of the Novel Vaccine on its completion," he added.

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(With PTI inputs)