The phase II study of ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation
Drug firm Zydus Cadila has received DCGI approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D. The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement.
ZyCoV-D was found to be safe, well-tolerated and immunogenic in phase I and II clinical trials, it added.
The phase II study of ZyCoV-D had been conducted in 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 drug firm said.
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.
“We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine,” Zydus Group Chairman Pankaj R Patel said.
The launch of the Phase 3 trial will determine the efficacy of the company’s vaccine in preventing COVID-19, which continues to pose a major threat world over, he added.
The Drug Controller General of India (DCGI) on Sunday granted emergency approval to Serum Institute and Bharat Biotech for their respective vaccines.