Zydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for COVID-19 vaccine

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By Economic Times – Zydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for COVID-19 vaccine SynopsisThe 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 Drug Controller General of India (DCGI) on Sunday granted emergency approval to Serum Institute and Bharat Biotech for their respective vaccines.Drug firm Zydus Cadila on Sunday said it 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.
(Catch all the Business News, Breaking News Events and Latest News Updates on The Economic Times.)Download The Economic Times News App to get Daily Market Updates & Live Business News.Also Read 3 Comments on this StorySubbu India2 hours agoThird Company in India going for clinical trial of corona vaccine. Hope they also succeed in their project.Subbu India2 hours agoThis time Zydus should complete the process before asking for emmergency use of their vaccine.A Singh2 hours agoGood to see an Indian Pharma company moving ahead with COVID vaccine trial.

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