Biznextindia : After Bharat Biotech, Zydus Cadila on Wednesday said that it has initiated the human clinical trials of its plasmid DNA vaccine ZyCoV-D with the first human dosing.
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.
“..The Adaptive Phase I/ II human clinical trials of its plasmid DNA vaccine, ZyCoV-D commenced today with the first human dosing. The Adaptive Phase I/II dose-escalation, the 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 company has informed the stock market.
“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 DGCI 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” Pankaj R. Patel, Chairman, Zydus Cadila.
Zydus had earlier this month announced that its plasmid DNA vaccine candidate (ZyCoV-D) developed at its Vaccine Technology Centre in Ahmadabad, India had successfully completed the preclinical phase and had received permission from the Drug Controller General of India – Central Drugs Standard Control Organisation (CDSCO) to initiate Adaptive Phase I/II human clinical trials in India.
Yesterday, Bharat Biotech announced the commencement of the human clinical trials of its COVID-19 vaccine ‘Covaxin’. The company is developing the vaccine, said to be India’s first COVID-19 vaccine, in collaboration with Indian Council of Medical Research (ICMR).
The Drug Controller General of India (DCGI) has approved the vaccines of Bharat Biotech and Zydus for Phase-I and Phase-II human clinical trials.