Zydus applies to DCGI for EUA to launch ZyCoV-D

Zydus Cadila announced that the company has applied for Emergency Use Authorization (EUA) to the office of the Drug Controller General of India (DCGI) for ZyCoV-D – its Plasmid DNA Vaccine against COVID-19. The company conducted a clinical trial for its COVID-19 vaccine in India so far in over 50 centers. The COVID-19 vaccine has been tested in adolescent population in the 12-18 years age group in India as well.

A company statement informed, “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 per cent 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 per cent 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.”

ZyCoV-D had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).

Speaking on the development, Dr Sharvil Patel, MD, Cadila Healthcare, said, “This breakthrough marks a key milestone in scientific innovation and advancement in technology. As the first-ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against COVID-19. The vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group. This has been possible because of the collective support of the Government, the regulators, the volunteers who had faith in the process, the investigators who conducted the multi-centric trials all through these months, the suppliers who worked closely with us and our dedicated team of researchers and vaccine professionals who worked tirelessly on the vaccine and also manufactured the trial doses.”

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.

Zydus also acknowledged the support of the National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, the National Institute of Virology, the Indian Council of Medical Research and PharmaJet® in the development of  ZyCoV-D vaccine.