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Clinical-trials of Vaccine-ZyCoV-D begins

Clinical-trials of Vaccine-ZyCoV-D begins

New Delhi: The Biotechnology Industry Research Assistance Council (BIRAC) has announced that ZyCoV-D, the plasmid DNA vaccine designed and developed by Zydus and partially funded by the Department of Biotechnology, Government of India has initiated Phase I/ II clinical trials in healthy subjects, making it the first indigenously developed vaccine for COVID-19 to be administered in humans in India.

The adaptive Phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine. The human dosing of the vaccine marks a key milestone since the launching of the accelerated vaccine development programme for COVID-19 in February 2020.

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “The DBT has partnered with Zydus to address rapid development of an indigenous vaccine for COVID-19 under the National Biopharma Mission. This partnership with Zydus is to serve the country’s need for a vaccine to fight the dreaded pandemic which has put a billion people at risk. Such research endeavours will help the country to develop preventive strategies for future disease outbreaks as well and exemplifies the government’s focus on creating an ecosystem that nurtures and encourages new product innovation to make real and measurable changes to issues most relevant to our society.”

Clinical-trials of Vaccine-ZyCoV-D begins

ZyCoV-D

In the pre-clinical phase, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.

With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with 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 couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

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