Zydus Cadila on Thursday announced that it has applied to the Drugs Controller General of India seeking Emergency Use Authorization (EUA) for ZyCoV-D - its Plasmid DNA vaccine against COVID-19. The firm has conducted the largest clinical trials in India for its vaccine at over 50 centres and its vaccine has been the first Covid vaccine in India to be tested on the adolescent population in the 12-18 years age group.
The firm said that it aims at producing up to 120 million doses of the shot annually.
The company in a statement said: "Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population. 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.”
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If the Zydus vaccine gets approval, it will become the fifth vaccine to be authorised for use in the country after AstraZeneca and partner Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Moderna and Sputnik V developed by Russia's Gamaleya Institute.
"ZyCoV-D had already exhibited 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), the statement further elaborated.
ZyCoV-D has displayed efficacy and safety on more than 28,000 participants in the late-stage trials, including about 1,000 subjects in the 12-18 year age group, Zydus said.
Zydus in a statement to the stock exchanges said that a study was initiated during the peak of the second wave of COVID-19 in India, underlining that its vaccine works effectively against the new mutant strains, especially the Delta variant.
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In another development, the firm has also assessed a two-dose regimen for the ZyCoV-D vaccine that will use a 3 mg dose per visit and the immunogenicity results were equivalent to the current three-dose regimen. This would help in decreasing the full course term of the vaccination and will also maintain a great safety profile of the vaccine in the future.