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, randomized, 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 outcomes.
Importance of Phase-3 Trials:
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.
Zydus Group Chairman Pankaj R Patel said “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.”
“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.
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).