DCGI approves phase 3 trial of Zydus two-dose vaccine

After getting an Emergency Use Authorization for its three-dose Covid-19 vaccine ZyCov-D, Cadila Healthcare Limited ( Zydus Cadila) has received a go-ahead for phase-III trials for its two-dose regimen.

The subject expert committee (SEC) of the regulator Drugs Controller General of India (DCGI) met last week and recommended phase-III trials of two-dose regimen of ZyCov-D, which comes in 3 mg strengths each.

The minutes of the panel’s latest meeting showed that SEC stated, “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for grant of permission to conduct the Phase III clinical trial subject to condition that, volume of blood to be withdrawn in the paediatric cohort shall be as per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by ICMR.”

The development comes in the backdrop of Zydus presenting a revised clinical trial protocol for conduct of Phase III clinical trial of the vaccine.

In August, the three-dose regimen got approval for administration to individuals above 12 years.

According to sources, the price of the vaccine is an area where there is still no clarity in the market.

No clarity on pricing
Earlier, Zydus Cadila MD Sharvil Patel had stated that the initial doses delivery was expected by end of September. However, sources stated that the pricing continues to be a vexed issue between the company and the government. Industry sources speculate the price for the three-dose vaccine to be in the range of ₹300-1,900 per dose.

There is, however, no word from the company officials on the same. The high cost of the vaccine is also attributed to the costly applicator for the intradermal administration.

The vaccine is expected to hit the market next month, as per reports. The Hindu BusinessLine