DCGI gives permission to conduct Phase III trial for two-dose C-19 vaccine

The drug regulator had approved Zydus’ vaccine on August 20 for emergency use in India.

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DCGI CDSCO

Last Updated on October 6, 2021 by The Health Master

India’s drug regulator Drugs Controller General of India (DCGI) has given permission to Zydus Cadila for conducting Phase III trial on the two-dose regimen of its needle-free C-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 C-19 vaccine.

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grant of permission to conduct the Phase III clinical trial subject to the condition that, the volume of blood to be withdrawn in the pediatric cohort shall be as per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by ICMR,” said the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

The drug regulator had approved Zydus’ vaccine on August 20 for emergency use in India.

The three-dose vaccine which is to be given 28 days apart is likely to be introduced in the vaccination drive this month.

The company was evaluating a 2 dose regime with 3mg in each dose.

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