Ahmedabad (Gujarat): Indian pharmaceutical giant Zydus Cadila on Wednesday announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe and well-tolerated in Phase I clinical trial. The company will now commence Phase II clinical trials from Thursday. The Company reports that the doses of the vaccine administered to healthy volunteers in Phase I clinical trial, which began on 15th July 2020, has been well-tolerated.
Previously, the vaccine was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies.
“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” said Mr Pankaj R. Patel, Chairman Zydus Cadila. “All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post-dosing for safety and for 7 days thereafter and the vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population.”
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The 7-day safety of the vaccine in all the subjects enrolled in Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial. The Phase II study of ZyCoV-D will be conducted in over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose-escalation, multicentric, randomized, double-blind placebo-controlled study.
With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe.
Further, no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).
The platform is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.
The plasmid DNA, when introduced into the host cells, would be translated into the viral protein and will elicit a strong immune response mediated by the cellular and humoral arms of the human immune system, which plays a vital role in protection from disease as well as viral clearance. Zydus acknowledges the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India in the development of ZyCoV-D. Zydus’ Vaccine research programme Vaccine Technology Centre of Zydus Cadila has a wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines for unmet needs. In fact, Zydus was the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010.
In past, it has also indigenously developed numerous vaccines successfully including tetravalent seasonal influenza vaccine (first company in India to indigenously develop and commercialize), Inactivated Rabies vaccine (WHO Prequalified), Varicella vaccine (first Indian company to indigenously develop and receive market authorization), Measles containing vaccines (MR, MMR, Measles), Typhoid conjugate vaccine, pentavalent vaccine (DPT-HepB-Hib) etc to name a few.
The company also has a strong pipeline of vaccines like Measles-Mumps-Rubella-Varicella (MMRV), Human papillomavirus vaccine, Hepatitis A, Hepatitis E vaccines which are at various stages of development.
