Zydus Cadila has applied to the Drugs Controller General of India (DCGI) for Emergency Use Authorisation (EUA) for it's DNA vaccine for COVID-19. The company is seeking approval for use of the vaccine on those aged 12 and above. The three dose vaccine has completed the third phase of trials and the company plans to manufacture 10-12 crore doses annually.
If approved, ZyCoV-D will be the fifth vaccine approved for use in India. However, this will be the only vaccine approved for use on children. According to a press note that the company shared with the stock exchanges indicates that around 1000 subjects between the ages of 12 and 18 were enrolled in the trials and the vaccine was found to be "safe and very well tolerated". The tolerability profile, the company adds, was similar to that seen in the adult population.
ZyCoV-D is a DNA COVID-19 vaccine, which carries the genetic code for that part of a virus that triggers the immune system of the body. The vaccine is being developed with support from the Centre's National Biopharma Mission as part of the Biotechnology Industry Research Assistance Council, Department of Biotechnology. It will be the second indigenous COVID-19 vaccine to apply for such authorisation as well as the world's first DNA vaccine against coronavirus.
"Primary efficacy of 66.6% has been attained for symptomatic RT-PCR positive cases in the interim analysis. Whereas, no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100% efficacy for moderate disease. No severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of the second dose of the vaccine," the company says.
"Study carried out in more than 50 clinical sites spread across the country and during the peak of second wave of COVID-19 reaffirming the vaccine’s efficacy against the new mutant strains especially the delta variant," the company adds.
ZyCoV-D is a three-dose vaccine -- to be administered at day 0, day 28, and day 56. The company has said it is also working on a two-dose regimen of this vaccine. It is touted as a 'needle free' vaccine that will be administered intradermally.
