Ahmedabad-based Zydus Cadila’s vaccine candidate for Covid-19 went into human trials on Wednesday, said the company. ZyCoV-D is the second Indian-origin vaccine candidate to go into human trials after Hyderabad-based Bharat Biotech's Covaxin.
"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," said Zydus Cadila in a statement.
“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/II clinical studies and gathering important data on ZyCoV-D in the months ahead,” said Pankaj R. Patel, chairman of Zydus Cadila.
Zydus, for human Adaptive Phase I/ II clinical trials, will enroll over 1000 subjects across multiple clinical study sites in India. It has already manufactured clinical GMP batches of the vaccine candidate for the clinical trials.
Zydus announced earlier this month that ZyCoV-D had successfully completed the pre-clinical phase and had received permission from the Drug Controller General of India to initiate Adaptive Phase I/II human clinical trials in India.
In the pre-clinical 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 neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate," the company said