Phase III trial data of DNA Covid vaccine may be submitted to DCGI this month: Zydus MD

The first indigenous DNA vaccine against Covid-19, ZyCoV-D being developed by Zydus Cadila with support from the Department of Biotechnology is undergoing the final phase of the clinical trial. In Phase I and II of the trial, conducted on over 1,000 healthy adult volunteers, the vaccine was found to be safe and elicited a strong immunogenic response.

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In an interview with DH’s Kalyan Ray, Zydus Group’s managing director Sharvil Patel spoke about ZyCoV-D that may very well be the second homegrown Covid-19 vaccine in India.

What’s the progress with the Phase III trial? When will the data be submitted to the DCGI for review?

"Our DNA plasmid vaccine against Covid-19, ZyCoV-D is in advanced phase III clinical trials. This is by far the largest trial being done in the country right now and we have recruited 28,000 plus volunteers for the trials. We are at a stage of the trial where we are waiting for event data (reaching a critical number of Covid-19 patients in the vaccine arm of the study) which is expected this month. Once we see the data, we will look forward to submitting it to the DCGI by the end of this month."

How long would it take for the company to start commercial production of the vaccine?

"After receiving the DCGI clearance... Once we get the approval, we could start supplying the vaccine in the month of June."

How many doses the company would like to manufacture and what’s the scale-up plan?

"We believe that by the end of this year, we can make around five crore doses available, we are looking at how to further scale it up in the next few months. We are also exploring tech transfers and partnerships."

Considering that it's a three-dose vaccine, do you think ZyCov-D would be at a disadvantageous position when compared against single dose or double dose vaccines?

"I believe that more than the number of doses, it is the safety and data which matters more. We believe a three-dose regimen is very optimum for creating a long and sustainable immunity as it will give a larger immune response and longer antibody response which we have seen in our data."

What’s the gap between the doses?

"We had kept a gap of four weeks as a part of the trials, so if the first dose was given on Day 0, and the successive doses were given on Day 28 and Day 56.

What’s the temperature range in which the vaccine will remain stable?

"One of the remarkable features about ZyCoV-D is that it is thermostable. It can remain stable at temperatures around 25 degrees Celsius for three to four months and for a longer period at 2-8 degrees."

What would be the price?

"The pricing of the vaccine will be decided closer to the launch, however, we at Zydus have right since the onset of the pandemic provided affordable therapeutics and diagnostic to the patients, ZyCoV-D too will be made affordable to the people."

Is there any plan to start a clinical trial of ZyCov-D on children?

"As a part of our phase III clinical trial, we have completed all of the major cohorts. In our trials, we have covered elderly citizens, people with comorbidities and adolescents in the age group of 12 to 18 years."