ZyCoV-D was discovered to be secure, well-tolerated and immunogenic in section I and II medical trials, it added.
The section II research of ZyCoV-D had been carried out in over 1,000 wholesome grownup volunteers as a part of the adaptive Phase I/II dose-escalation, multi-centric, randomised, double-blind placebo-controlled research, the drug agency stated.
The trial has reviewed by an unbiased information security monitoring board (DSMB) and reviews had been submitted to the Central Drugs Standard Control Organisation (CDSCO) commonly for the replace on security final result.
“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 stated.
The launch of the Phase Three trial will decide the efficacy of the corporate’s vaccine in stopping Covid-19, which continues to pose a serious menace world over, he added.
The Drug Controller General of India (DCGI) on Sunday granted emergency approval to Serum Institute and Bharat Biotech for his or her respective vaccines.