"The Adaptive Phase I/ II human clinical trials of plasmid DNA vaccine, ZyCoV-D have commenced with the first human dosing. 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.
This is an all important step in our fight against COVID-19. We acknowledge the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt. of India and regulatory agencies ICMR and DCGI in the development of ZyCoV-D vaccine candidate.
We look forward to the Adaptive Phase I/IIclinical studies and gathering important data on ZyCoV-D in the months ahead.
In the Adaptive Phase I/ II clinical trials, Zydus will be enrolling over 1000 subjects across multiple clinical study sites in India. The company has already manufactured clinical GMP batches of the vaccine candidate for the clinical trials."
- Pankaj R. Patel, Chairman, Zydus Cadila, Ahmedabad
