Paving way for the timely roll out of another indigenous Covid-19 vaccine, the Drugs Controller General of India (DCGI) has approved phase-3 clinical trials of Ahmedabad-based Cadila Healthcare Ltd (Zydus Cadila)'s plasmid DNA vaccine 'ZyCov-D'.
With this, Zydus Cadila will now initiate phase-3 clinical trials in around 30,000 volunteers. According to Zydus Group chairman Pankaj Patel, the launch of the phase-3 trials will determine the efficacy of the vaccine in preventing Covid-19.
The company had applied for permissions with the DCGI after the phase-2 study of the ZyCov-D vaccine was conducted in over 1,000 healthy adult volunteers. The study was part of the adaptive Phase I/II dose escalation, multi-centric, randomised, double-blind placebo controlled study.
The vaccine was found to be safe and elicit a strong immunogenic response during the study.
The trial was reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.
According to Patel, the nod for phase 3 clinical trials amounts to the group reaching a critical milestone in its vaccine development programme and towards its goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine.
Meanwhile, depending on the progress of the study and the outcomes, Zydus is hoping to launch ZyCov-D vaccine in the first quarter of next financial year.
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