Cadila Healthcare gets CDSCO panel nod to conduct phase 3 study of ZydCov-D in 2-dose schedule

However, the nod is subject to the condition that the volume of blood to be withdrawn in the paediatric cohort shall be as per the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by ICMR.

This came after Cadila Healthcare presented a revised clinical trial protocol for the conduct of a Phase III clinical trial of the Novel Corona Virus-2019-nCov vaccine (Recombinant) 3mg in a two-dose schedule before the committee.

Earlier, the Medical Dialogues Team had reported that Zydus Cadila had said in a press statement that the company intends to pursue clearance for the vaccine's two-dose schedule and accordingly the company was getting ready to submit a revised application to the Central Drugs Standard Control Organization (CDSCO), seeking that the vaccine be provided in two doses.

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

Last month, Zydus Cadila received Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for the needle-free 3-dose Covid-19 vaccine ZyCoV-D for adolescents in the 12-18 age group, besides the adult population. ZyCoV-D is a needle-free vaccine administered using the PharmaJet, a needle-free applicator that ensures painless intradermal vaccine delivery.

Earlier, at175th SEC meeting , Cadila Healthcare presented immunogenicity data of Phase I/II clinical trial of Novel Corona Virus - 2019- nCov vaccine 3 mg (two dose regimen day 0 & 28) along with Summary Product Characteristics (SmPC),Prescribing information (PI).

Responding to this, the committee noted that Phase I/II clinical trial of 3 mg dose (two dose regimen) was conducted in the age group of 18 years and older. As a result, with regards to two dose (3mg) regimen the committee recommended that the firm should generate additional data and also submit safety protocol for further consideration.

Now, moving further, at 185th SEC meeting to examine COVID-19 related proposal under accelerated approval process held on 23.09.2021 at CDSCO, the SEC expert panel thoroughly examined the Cadila Healthcare's revised clinical trial protocol of Phase III clinical trial of Novel Corona Virus-2019-nCov vaccine (Recombinant) 3mg in two dose.

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 pediatric cohort shall be as per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by ICMR.