India's Zydus begins human trials for potential COVID-19 vaccine
Coronavirus vaccine
Indian pharmaceutical company Zydus has started human studies for its potential COVID-19 vaccine, as coronavirus infections continue to surge in the world's third worst-hit nation.
ZyCoV-D, its plasmid DNA vaccine, was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies, Zydus said on Wednesday.
The human dosing of the vaccine marks a key milestone since the launching of the accelerated vaccine development programme for COVID-19 in February, the company said.
"We acknowledge the support of National Biopharma Mission, BIRAC, Department of Biotechnology and regulatory agencies ICMR and DGCI in the development of ZyCoV-D vaccine candidate," Chairman Pankaj R Patel said.
In the human trials, Zydus will enrol over 1,000 subjects across multiple clinical study sites in India.
The company has already manufactured clinical GMP batches of the vaccine candidate for clinical trials.
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In the pre-clinical phase, the vaccine was found to generate a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.