DCGI nod to phase III trials of Cadila Healthcare two-dose COVID vaccine
New Delhi: Drug firm Cadila Healthcare on Tuesday said it has received permission from the Indian drug regulator for conducting phase III trials for its two-dose COVID-19 vaccine ZyCoV-D.
The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20, reports PTI.
The company has "... got the permission for conduct of phase III trials for two-dose Covid vaccine," Cadila Healthcare said in a regulatory filing.
Earlier in August, in a filing to BSE, Cadila Healthcare had said that it plans to seek approval for the two dose regimen of the vaccine. It had also mentioned that the company plans to manufacture 10-12 crore doses of ZyCoV-D annually.
ZyCoV-D, is a needle-free vaccine administered using The PharmaJet a needle free applicator, which ensures painless intradermal vaccine delivery.
Last month, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) had granted the Cadila Healthcare the right to conduct a Phase III clinical trial of the Novel Corona Virus-2019-nCov vaccine (Recombinant) 3mg in a two-dose schedule.
Read also: Cadila Healthcare gets CDSCO panel nod to conduct phase 3 study of ZydCov-D in 2-dose schedule
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