Phase II trials of the vaccine ZyCoV-D conducted in more than 1,000 healthy adult volunteers as part of an adaptive phase I / II dose escalation, multicenter, randomized, double-blind, placebo-controlled trial it was done. The vaccine turned out to be safe and immunogenic.
“The Zydus Cadila COVID-19 vaccine was found to be safe in Phase I and Phase II clinical trials.”
The study is reviewed by an independent data safety monitoring committee (DSMB) and regularly submitted to the Central Pharmaceutical Standards Control Organization (CDSCO) for up-to-date information on safety results.
Pankaj R, Chairman of the Zydus Group. Patel said: “After establishing safety in Phase I clinical trials, ZyCoV-D completed Phase II clinical trials and found that the vaccine was safe and immunogenic. The results of the clinical trials were similar and successful. We believe we can start producing new vaccines when they are completed. ”
According to the statement, ZyCoV-D has helped the company establish a DNA vaccine platform in the country.
The platform is also known to have lower cold chain requirements due to significantly improved vaccine stability. This makes the vaccine ideal for access in the farthest parts of the country. It is easy to administer because it is administered by the intradermal route. In addition, the platform facilitates vaccine production with minimal biosafety requirements (BSL-1). In addition, the platform can be used to quickly change vaccines in weeks in case the virus mutates, ensuring that the vaccine still elicits protection.
When introduced into a host cell, plasmid DNA is translated into viral proteins, eliciting a strong immune response mediated by the cellular and humoral arms of the human immune system. It plays an important role in protecting against illness and viral clearance. .. Zydus would like to thank the National Biopharma Mission, BIRAC, Department of Biotechnology, ICMR, and NIVPune for their support in the development of ZyCoV-D.