Zydus Cadila applies for emergency use nod for Covid vaccine
New Delhi: Indian drugmaker Zydus Cadila has applied to the Drugs Controller General of India (DCGI) on Thursday for emergency use approval of its COVID-19 vaccine.
Reportedly, the company conducted the clinical trial for its COVID-19 vaccine in India in over 50 centers. The vaccine has been tested in adolescent population in the 12-18 years age group in India.
The vaccine has completed the third phase of trial and has plan to manufacture up to 120 million doses of the shot annually, added reports.
“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,” the company said in a statement.
The approval for Zydus’ vaccine, ZyCoV-D, would make it the fifth vaccine authorized for use in India, after Moderna, Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, and Sputnik V developed by Russia’s Gamaleya Institute.