Early clinical trial of ZyCoV-D establishes safety

Zydus Cadila, a part of Cadila Healthcare (BOM: 532321), has announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe and well tolerated in the Phase I clinical trial. The company will now commence Phase II clinical trials from August 6, 2020.

The company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, which began on July 15, 2020, has been well tolerated. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.

“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” said Pankaj Patel, chairman of Zydus Cadila. “All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for seven days thereafter and vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” he noted.