The plasmid DNA vaccine ZyCoV-D, designed and developed by Zydus and partially funded by the Department of Biotechnology is the second potential vaccine candidate after Bharat Biotech’s COVAXIN which got the approval for human clinical trial by the Central Drug Standard Control Organisation.
Biotechnology Industry Research Assistance Council has announced that ZyCoV-D has initiated phase-I and II clinical trials on healthy subjects.
The adaptive phase-I and 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.
The Secretary of Department of Biotechnology and Chairperson of BIRAC, Dr. Renu Swarup said, this is an important milestone for AtmaNirbhar Bharat as Zydus begins human clinical trials for the indigenously developed vaccine.
She hoped 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. She termed this development a big leap forward for Indian scientific research.
Dr. Swarup said, this partnership with Zydus is to serve the country’s need for a vaccine to fight the pandemic which has put billions of people at risk.
Speaking on the development, Chairman of Zydus Cadila, Pankaj Patel said, this is a very important step in our fight against this pandemic and it will help the nation combat this healthcare challenge.
He thanked the government for their support in developing a safe and efficacious vaccine to prevent COVID 19.
The Zydus’ vaccine ZyCoV-D is developed indigenously at the company’s Vaccine Technology Centre in Ahmedabad after completing the preclinical 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 completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate.