Phase-3 trials to begin on two-dose regimen

In a meeting held last month, the Subject Expert Committee (SEC), which advises the drug regulator-granted permission to the company for conducting Phase III trials on its vaccine.

India's drug regulator has given permission to Zydus Cadila for conducting Phase III trial on the two dose regimen of its needle free Covid-19 vaccine, ZyCoV-D. In a meeting held last month, the Subject Expert Committee (SEC), which advises the drug regulator-granted permission to the company for conducting Phase III trials on its vaccine.

"After detailed deliberation, the committee recommended for grant of permission to conduct the Phase III clinical trial subject to condition that, volume of blood to be withdrawn in the pediatric cohort shall be as per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by ICMR," said the minutes of the meeting.
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