New Delhi: Zydus Cadila today announced that the company has applied for Emergency Use Authorization (EUA) to the office of Drug Controller General of India (DCGI) for ZyCoV-D.
An approval for Zydus’ vaccine, ZyCoV-D, would make it the fifth vaccine authorized for use in India, after Moderna, AstraZeneca and partner Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, and Sputnik V developed by Russia’s Gamaleya Institute.
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, Zydus said.
The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centers. This was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age group in India.
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 had been found to be 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.
