Ahmedabad based drugmaker Zydus Cadila has applied for Emergency Use Authorisation (EUA) to the country’s regulator DCGI for ZyCoV-D- its COVID-19 vaccine.
The vaccine that is meant for use among all age groups, and can be used for those aged 12 years and above has concluded its third phase trials of the vaccine. The drugmaker has claimed that it has carried out the largest clinical trials for its Plasmid DNA vaccine against coronavirus in India, in more than 50 centres.
“Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. Tolerability profile was similar to that seen in the adult population and primary efficacy of 66.6% was 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,” Zydus Cadila said in a statement.
The company added that it plans to produce up to 120 million doses of the jab annually, once it gets the regulator’s nod.
According to the company, ZyCoV-D had already exhibited a robust immunogenicity, tolerability and safety profile in the adaptive Phase me/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.
This was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age bracket in the country.
Zydus’ vaccine named as ZyCoV-D if approved, would be the fifth vaccine authorized for use in India, after Serum Institute of India’s Covishield licensed by Astra Zeneca , Bharat Biotech’s Covaxin, and Sputnik V developed by Russia’s Gamaleya Institute and Moderna which applied for EUA yesterday.
According the company, ZyCoV-D showed safety and efficacy in a late-stage trial with more than 28,000 volunteers across the country, including about 1,000 subjects in the 12-18-year age group.
The study was reportedly carried out during the peak of second wave of COVID-19 in India and confirms the vaccine’s efficacy against the new mutant strains, especially the Delta variant which is wreaking havoc in Europe and many other countries.
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