Delhi: 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 indigenous developed vaccine for Coronavirus 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.
Zydus claimed that vaccine has received strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits in the pre-clinical phase. 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. Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC said,
“The Department of Biotechnology Government of India 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.”
Dr. Swarup also mentioned that, “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, Chairman of Zydus Cadila, Pankaj R. Patel said, “This is a very important step in our 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.”