Ahmedabad-based Cadila Healthcare Ltd (Zydus Cadila)’s plasmid DNA vaccine ‘ZyCov-D’ has got approval for its phase-3 clinical trials from the Drugs Controller General of India (DCGI). It has paved way for the timely launch of another home-grown Covid-19 vaccine. As a result, now Zydus Cadila will begin phase-3 clinical trials in approx. 30,000 volunteers. As per a statement by Zydus Group chairman Pankaj Patel, the introduction of the phase-3 trials will determine the effectiveness of the vaccine in stopping Covid-19. The phase-2 study of the ZyCov-D vaccine was led in over 1,000 healthy adult volunteers. After this, the firm had applied for permissions with the DCGI.
The study was done under the adaptive Phase I/II dose escalation, multi-centric, randomised, double-blind placebo-controlled study. During the study, the vaccine was found to be safe and elicit a strong immunogenic response. An independent Data Safety Monitoring Board (DSMB) had reviewed the trial. And for the update on safety outcome, the board submitted the reports to Central Drugs Standard Control Organisation (CDSCO) regularly. As per Patel, the approval for phase 3 clinical trials leads to the group reaching a critical milestone in its vaccine development programme. Apart from this, it will ensure its aim of helping people fight the pandemic with an indigenously discovered, safe and effective vaccine.
In the meantime, Zydus is aspiring to introduce ZyCov-D vaccine in the first quarter of next financial year. This will depend on the progress of the study and the outcomes. Apart from this, India has approved two indigenous covid vaccine for emergency use.