Zydus Cadila has been granted permission by India’s drug regulator to conduct a Phase III trial on the two dose regimen of its needle-free Covid-19 vaccine, ZyCoV-D. The Subject Expert Committee (SEC), which advises the drug regulator, granted the company permission to conduct Phase III trials on its vaccine at a meeting last month.
“After careful consideration, the committee recommended that permission be granted to conduct the Phase III clinical trial, subject to the condition that the volume of blood to be withdrawn in the paediatric cohort be in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by the ICMR,” according to the meeting minutes.
