NEW DELHI: The Department of Biotechnology under the Union Ministry of Science and Technology has announced that ZyCoV-D, the plasmid DNA vaccine candidate designed and developed by Zydus, has entered Phase I/II clinical trials. This makes it the first indigenously developed vaccine candidate for COVID-19 to be administered to 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 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.”
She also added, “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, Mr. 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.”
In the pre-clinical phase, the vaccine candidate 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 candidate were able to neutralize the wild type virus in virus neutralization assay indicating its protective potential. 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.