Zydus applies to DCGI for EUA to launch ZyCoV-D

Presents interim results from Phase III clinical trials in over 28,000 volunteers

Zydus Cadila has applied for Emergency Use Authorization (EUA) to the office of Drug Controller General of India (DCGI) for ZyCoV-D – its Plasmid DNA Vaccine against COVID-19. The company conducted the clinical trial for its COVID-19 vaccine in India so far in over 50 centres. This was also the first time that any COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India. Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. 


Dr Sharvil Patel, MD, Cadila Healthcare, said, “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 and the immunogenicity results were equivalent to the current three-dose regimen. This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future. 

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