Zydus Cadila applies to DCGI for EUA to launch ZyCoV-D

01 Jul 2021 Evaluate

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 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. 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.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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