The Drugs Controller General of India (DCGI) has permitted Zydus Cadila to conduct Phase III trials of ZyCoV-D, the two-dose regimen of its needle-free Covid vaccine.
The company has “got the permission to conduct Phase III trials for its two-dose Covid vaccine”, Cadila Healthcare said in a regulatory filing.
Zydus Cadila had started testing the two-dose regime of the vaccine with 3 mg in each dose soon after being granted an Emergency Use Authorisation (EUA).
The Ahmedabad-based healthcare manufacturer’s three-dose RNA vaccine, apart from two-dose one, will soon be introduced under India’s mass vaccination drive.
The talks with the government are underway on pricing issues for the three-dose RNA vaccine which is supposed to be rolled out this month.
The company is said to have proposed a price of Rs 1,900 for its three-dose jab, but the Union government is negotiating for a reduction in price.
Health Secretary Rajesh Bhushan had said earlier, “As far as the price of the vaccine at which it will be procured is concerned, we are in conversations with the manufacturer. Since it is a three-dose vaccine and comes with a needleless delivery system, it would have a differential pricing than the existing vaccines that are being used in the Covid vaccination programme.”
The ZyCov-D vaccine was approved by the DCGI on August 20.
The RNA built ZyCoV-D vaccine will be administered in three doses — the second dose will be administered on day 28 from the first dose and the third one 56 days from the first dose.