Zydus Cadila seeks DCGI nod for emergency use of its Covid-19 vaccine ZyCoV-D

The Phase 3 trials on more than 28,000 volunteers across 50 clinical sites, have shown an efficacy rate of 66.6%. That is lower than the efficacy levels of vaccines from Moderna and Pfizer-BioNTech that use mRNA technology.

Zydus Cadila, which has sought the approval of DCGI for emergency use authorisation of its vaccine ZyCoV-D following its efficacy in clinical trials, is on track to manufacture 50 million doses between August and December.

The Phase 3 trials on more than 28,000 volunteers across 50 clinical sites, have shown an efficacy rate of 66.6%. That is lower than the efficacy levels of vaccines from Moderna and Pfizer-BioNTech that use mRNA technology.

Trials were done during the peak of second wave of Covid during April, May and June indicating the vaccine’s efficacy against the new mutant strains especially the delta variant, managing director Sharvil Patel said on Thursday.

This is the country’s second home-grown vaccine and world’s first Plasmid DNA one for Covid and will be administered using the PharmaJet, a needle free applicator for painless intra-dermal vaccine delivery.

Patel said the company was looking at a time frame of 45 to 60 days for the launch once it receives regulatory approvals. He added that ZyCoV-D had initially been a three-dose vaccine but two doses had shown comparable efficacy. Data has been submitted both for the two-dose and three-dose regimen. The vaccine needs to be administered with a gap of 28 days between the doses.

Cadila has set up new facilities to make ZyCoV-D since the technology is a new one and has invested around `400-500 crore. Around four to five lakh doses of the vaccine are being made currently and capacity is being scaled up to make 10-12 crore doses annually, Patel said. The price of the vaccine, which needs to be stored at 2-8 degrees Celsius, has not been fixed yet and would depend on the dosage and other factors.

This is the first time that any Covid-19 vaccine has been tested in the 12-18 years age group in India with 1,000 subjects participating in the trial. Patel said the tolerability profile was similar to that seen in the adult population. The study showed that ZyCoV-D is safe for children in the age group of 12 to 18 years.

The company has also evaluated a two-dose regimen for the ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three dose regimen. This will help reduce the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future. Patel said the company is talking to potential partners for making the vaccines.