Cadila Healthcare Ltd (Zydus Cadila) on Thursday informed that its plasmid DNA vaccine to prevent Covid-19, ZyCoV-D, was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials.
The company has now sought approval to initiate Phase-III clinical trials in around 30,000 volunteers.
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, a statement said here.
The vaccine was found to be safe and immunogenic. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB), and reports have been submitted to the Central Drugs Standard Control Organisation (CDSCO) for update on the safety outcome.
Pankaj R Patel, Chairman of the Zydus Group, said, “After establishing safety in Phase-I clinical trial, ZyCoV-D has now completed Phase II clinical trials and the vaccine has been found to be safe and immunogenic.”
“We are optimistic of Phase III clinical trial outcomes as well and that we would be able to start the production of the novel vaccine on its successful completion.”
Zydus Cadila has successfully established that its DNA vaccine platform shows much improved vaccine stability, thus requiring lower cold chain requirements. This makes the vaccine ideal for access in remotest regions of the country.
Allows easy modification
Administered through the intradermal route, it also allows for the ease of administration. Further, the platform also provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).
Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.