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Zydus Cadila Obtains DCGI Approval to Start Phase 3 Clinical Trials for Covid-19 Vaccine | India News


NEW DELHI: Pharmaceutical firm Zydus Cadila said Sunday that it received approval from DCGI to begin phase III clinical trials of its Covid-19 vaccine, ZyCoV-D.
The company will now begin a phase III clinical trial in about 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, he added.
The phase II study of ZyCoV-D had been conducted in more than 1,000 healthy adult volunteers as part of the adaptive phase I / II dose escalation, multicenter, randomized, double-blind, placebo-controlled study, the pharmaceutical firm said.
The trial has been reviewed by an independent data safety monitoring board (DSMB) and reports have been sent to the Central Medicines Standard Control Organization (CDSCO) regularly for updating of safety results.
“We are reaching a critical milestone in our vaccine development program and towards our goal of helping people fight the pandemic with a safe and effective vaccine discovered in indigenous peoples,” said Zydus Group President Pankaj R Patel.
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 around the world, he added.
The Comptroller General of Drugs of India (DCGI) on Sunday granted emergency approval to the Serum Institute and Bharat Biotech for their respective vaccines.

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