ZyCoV-D, the plasmid DNA vaccine designed and developed by Zydus and funded by the Department of Biotechnology, India, has initiated Phase one and two clinical trials, 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, an official release said.
Biotechnology Industry Research Assistance Council chairperson and DBT secretary Dr. Renu Swarup said, “the Department of Biotechnology has partnered with Zydus to address rapid development of an indigenous vaccine for COVID-19 under the National Biopharma Mission. This is an important milestone for AtmaNirbhar Bharat as Zydus begins human clinical trials for the indigenously developed vaccine. We hope, that the vaccine continues to show positive outcomes as it has done so far in the pre-clinical phase where it was found to be safe, immunogenic and well tolerated. This will be a big leap forward for Indian scientific research.”
Speaking on the development, Zydus Cadila Chairman of Pankaj R Patel said that this was an important step in the fight against this pandemic and one that will help the nation combat this healthcare challenge. “We are thankful to BIRAC and the Department of Biotechnology, Government of India for their support in our quest to provide a safe and efficacious vaccine to prevent COVID 19,” he said.
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, the release said. 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.