Zydus Cadila seeks govt. nod to start Phase III clinical trials

Zydus Cadila has announced that its 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 and has asked government to give go ahead for Phase III clinical trials.

The company is now planning to initiate Phase III clinical trials in around 30,000 volunteers upon receiving necessary approvals.

The Phase II study of the vaccine ZyCoV-D had been conducted in over 1000 healthy adult volunteers as part of the adaptive Phase I/II dose escalation, multi-centric, randomized, 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 outcomes.

Speaking on the development, Pankaj R. Patel, Chairman, Zydus Group said, “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 successful completion. I would like to thank all the volunteers who have participated in the study so far and helped us in evaluating the vaccine to fight COVID-19”.

The plasmid DNA when introduced into the host cells would be translated into the viral protein and will elicit a strong immune response mediated by the cellular and humoral arms of the human immune system which play a vital role in protection from disease as well as viral clearance.

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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