Zydus Cadila has made an announcement on Thursday that its plasmid DNA vaccine to prevent COVID-19 - ZyCoV-D - was found to be safe, well tolerated and immunogenic in the phase I and II clinical trials. The company is now planning to start phase III clinical trial involving around 30,000 volunteers upon receiving necessary approvals.
The phase II study of the vaccine ZyCoV-D was conducted involving over 1,000 healthy adult volunteers as part of the adaptive phase I/II dose escalation, multi-centric, randomised, double-blind placebo controlled study. The vaccine was found to be safe and immunogenic. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome. With ZyCoV-D, the company has successfully established the DNA vaccine platform in the country, a statement from the company said.
Pankaj R. Patel, Chairman of the Zydus Group said, "After establishing safety in phase I clinical trial, ZyCoV-D has now completed Phase II clinical trials and the vaccine has been found to be safe and immunogenic. We are optimistic of phase III clinical trial outcomes as well and that we would be able to start production of the novel vaccine on its successful completion." Zydus acknowledges the support of National Biopharma Mission, BIRAC, Department of Biotechnology, ICMR and NIV Pune in the development of ZyCoV-D.
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