Zydus Cadila said on Wednesday that its coronavirus vaccine has been found safe and effective in Phase I of the clinical trials. It said that Phase II clinical trials would start on August 6. The company said that the COVID-19 vaccine, ZyCoV-D, was administered to healthy volunteers in Phase I of the trials. It was found that the coronavirus vaccine is safe and well tolerated by the volunteers. The Phase I of the trials had started on July 15.
Before the clinical trials, the pre-clinical toxicity studies highlighted that the coronavirus vaccine was safe, immunogenic and well tolerated. The COVID-19 vaccine was able to elicit high level of neutralising antibodies in animal studies.
"The Phase I dosing to establish the safety of ZyCoV-D is an important milestone. 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 7 days thereafter and the 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," said Pankaj R Patel, Chairman Zydus Cadila.
The Phase II trial will evaluate the humoral and cellular immune response for the coronavirus vaccine candidate, keeping in line with the current global protocols. The neutralising potential of the COVID-19 would be tested as well as the humoral response up to 6 months from the last dosage, the company stated.
Zydus Cadila stated that the company has successfully established the DNA vaccine platform. Among other benefits, the platform also provides ease of manufacturing with minimal biosafety requirements. "The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. 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," stated the pharma company.