Ahmedabad-based pharmaceutical firm Zydus Cadila has requested emergency use approval for its ZyCoV-D three-dose Covid shot that is the world’s first Plasmid DNA vaccine. Zydus claims its vaccine is 66.6 per cent effective against symptomatic Covid cases and 100 per cent for moderate disease.
It also says the vaccine is safe for children between 12 and 18 years. But its trial data is not peer-reviewed yet. The vaccine, which is in its second phase of trials, is a “plasmid DNA” vaccine that can be stored at 2-8 degree Celsius.
According to Dr Sharvil Patel, Managing Director, Cadila Healthcare, the vaccine has shown primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases.
“The Vaccine has shown primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases in the interim analysis. Once the approval comes through- we can launch ZyCoV-D in 45-60 days,” he said.
“No severe cases or deaths because of COVID1-9 after the second dose of the vaccine were found and no moderate or severe case of COVID-19 disease were observed after the third dose," he added.
Patel said that a study carried out in more than 50 clinical sites spread across the country and during the peak of second wave of COVID-19 “reaffirmed the vaccine’s efficacy against the new mutant strains, especially against the delta variant”.
“The plasmid DNA platform is ideally suited for dealing with COVID-19 as it can be easily adapted to deal with mutations in the virus,” he said.
“We evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results were found to be equivalent to the current three dose regimen,” he added.
The company is planning to manufacture 10 to 12 crore doses annually. The price of the vaccine and that of the applicator will be different. “It’s not decided yet if it will be clubbed together,” Patel said.
The vaccine is being developed with support from the Centre’s National Biopharma Mission as part of Biotechnology Industry Research Assistance Council, department of biotechnology.
With ZyCoV-D, the Indian firm has established a DNA vaccine platform that uses a non-replicating plasmid, which carries the gene of interest. It means the vaccine will push the body to build antibodies against the coronavirus, as the inserted DNA sequence will match the sequence pattern of the virus.