DCGI nod to phase III trials of Cadila Healthcare two-dose COVID vaccine

Written by Ruchika Sharma Published On 2021-10-06T16:05:28+05:30 | Updated On 8 Dec 2022 2:29 PM IST

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.

The main advantage of DNA vaccines is their ability to stimulate both the humoral and cellular arms of the adaptive immune system. They are a valuable form of antigen-specific immunotherapy, as they are safe, stable and can be easily produced.

Zydus Cadila's ZyCoV-D when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response that plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.

Read also: Zydus Cadila ZyCov-D To Seek CDSCO Nod For Two-Dose Regimen: Report

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.

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Source : PTI

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751