Cadila Healthcare (CHL), also known as Zydus Cadila, will submit data related to its vaccine candidate ZyCov-D by end of May and hopes to receive approval from the regulators in June itself.
“Our vaccine trial for ZyCoV-D which is a plasmid DNA vaccine is progressing well. It is by far the largest trial being done in the country right now and we have recruited 28,000-plus volunteers for the vaccine. The Phase III trials of our vaccine will be truly representative of the efficacy of the vaccine against many of the known variants as different variants have surfaced in this wave. So the trial outcomes will have more representative efficacy data than any other vaccine,” Zydus Group managing director Dr Sharvil Patel was quoted as saying by the Financial Express.
“We are looking to submit the data by the end of May and eventually look for an approval in June,” Patel said.
Phase 3 clinical trials of Cadila’s vaccine candidate ZyCov-D is underway.
Ahmedabad-based Cadila is working towards getting approval not only for those above 18 years of age, but also for children above 12.
According to the company, ZyCov-D can be administered to children, who would require three doses of vaccine.
FE quoted sources close to the development as saying that CHL has tested its vaccine candidate ZyCov-D on more than 1,500 children.
No other vaccine has been tested for children in India yet.
ZyCoV-D was found to be safe during phase I and II trials.
Zydus Cadila plans to produce around 240 million doses per annum at Ahmedabad and Vadodara once it gets approval.