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Cadila Healthcare (Zydus Cadila) has applied for the Emergency Use Authorization (EUA) to the office of the Drug Controller General of India (DCGI) for its Plasmid DNA Vaccine for Covid-19 - ZyCoV-D, the company informed.
The company has presented interim results from Phase III clinical trials in over 28,000 volunteers. It it claims to be the largest clinical trial for its Covid-19 vaccine far across over 50 centres in India. Once granted EUA, Zydus plans to manufacture 10-12 crore doses annually.
The study demonstrates safety and efficacy in the interim data from the trial.
Needle free and safe for children
ZyCoV-D is found to be safe for children in the age group of 12 to 18 years - a first for any Covid-19 vaccine, the company said on Wednesday.
Around 1,000 subjects were enrolled in this age group. The vaccine was safe and well-tolerated, the company said that the tolerability profile was similar to that in the adult population.
The vaccine will be administered in a needle-free way, intradermally, using the PharmaJet, a needle-free applicator for painless vaccine delivery.
Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, "This breakthrough marks a key milestone in scientific innovation and advancement in technology. As the first-ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against Covid-19."
Primary efficacy of 66.6 per cent 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 per cent 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.
ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier.
Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
Plug and play technology
The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with Covid-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring
Patel further informed, "The vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group."
In another development, the Company has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit. The immunogenicity results were found to be equivalent to the current three dose regimen.
This will further help reduce the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future.
Zydus received support from National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, National Institute of Virology, Indian Council of Medical Research and PharmaJet® in the development of ZyCoV-D vaccine.
When injected, plasmid DNA vaccine - ZyCoV-D - produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.
ZyCoV-D is stored at 2-8 degrees Celsius but has shown good stability at temperatures of 25-degrees for at least three months.
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