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

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 been 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.

The Drugs Controller General of India (DCGI) granted approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situations," DCGI V G Somani told the media here.

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This clears the way for the roll-out of at least two vaccines in India in the coming days.

"Serum and Bharat Biotech vaccines have to be administered in two doses," Somani said, adding these vaccines have to be stored at 2-8 C.

"We will never approve anything if there is even the slightest safety concern. Vaccines are 110 percent safe. Some side effects like mild fever, pain, and allergy are common for every vaccine," Somani told reporters after the press briefing.

(Disclaimer: Additional background information has been added to this PTI copy for context)