Zydus Cadila gets DCGI approval for Phase Ill trial of ZyCoV-D
The company will now be initiating Phase III clinical trial in around 30,000 volunteers
Zydus Cadila announced that it will be starting Phase III clinical trials of it plasmid DNA vaccine to prevent COVID-19, ZyCoV-D after getting permission from the DCGI.
The company will now be initiating Phase III clinical trial in around 30,000 volunteers. ZyCoV-D was found to be safe, well-tolerated and immunogenic in the Phase I/II clinical trials.
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 elicit a strong immunogenic response. The trial has reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.
Speaking on the development, Pankaj R Patel, Chairman of the Zydus Group said, “The launch of the Phase 3 trial will determine the efficacy of our vaccine in preventing COVID-19 which continues to pose a major threat, the world over.”