Pharmaceutical company Zydus Cadila on Wednesday said its coronavirus vaccine candidate was found to be safe, immunogenic, and well-tolerated in an early-stage human trial. In a regulatory filing, the firm said it will start Phase II trials in over 1,000 healthy adult volunteers from Thursday to test its effectiveness against the infection.
“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” Zydus Cadila chairperson Pankaj R Patel said. “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 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.”
The seven-day safety of the vaccine candidate in volunteers enrolled in the Phase I trial, who were administered doses since July 15, was endorsed by an independent data safety monitoring board, the company said. The board was constituted to oversee the safety aspects of the clinical trial.
“The Phase II trial will be evaluating the humoral and cellular immune response for the vaccine candidate in line with the current global clinical trial protocols in general,” Cadila Healthcare, the listed entity of the group, said in the filing. “The neutralization potential of the antibodies elicited by the vaccine would also be checked by virus neutralization assay. The durability of the humoral response up to 6 months post last dose will also be evaluated.”
Last month, the Gujarat-based pharmaceutical giant received approval from domestic authorities to start human trials of the vaccine candidate ZyCoV-D. It plans to complete late-stage trials for the vaccine by February or March and could produce up to 100 million doses a year initially. There are currently no approved vaccines to cure the coronavirus.
India recorded 56,282 new coronavirus cases on Thursday, taking the total number of infections to 19,64,536. The toll rose by a record 904 to 40,699.