Zydus Cadila stated that the vaccine doses given to healthy volunteers in the Phase I clinical trial, which began on July 15, 2020, were well tolerated. Previously, the vaccine has been shown to be safe, immunogenic and well tolerated in preclinical toxicity studies.
The vaccine may discharge a higher point of neutralizing antibodies in animal studies, Zydus Cadila said.
“The Phase I dose to identify the protection of ZyCoV-D is a vital step,” said Pankaj R. Patel, president of Zydus Cadila. “All subjects in the Phase I clinical trial were intensively monitored in a clinical pharmacology unit for 24 years. Hours after management for protection and for 7 days thereafter, and the vaccine proved to be very safe. We are now starting Phase II clinical trials and are ahead of comparing the protection and immunogenicity of the vaccine in a wider population.”
Zydus Cadila said the Phase II trial will compare the vaccine candidate’s fun cellular immune reaction. The one to neutralize vaccine-induced antibodies would also be tested by a virus neutralization test. It will also compare the durability of the funny reaction up to 6 months after the last dose, he added.
Globally, more than one hundred candidate vaccines are being developed and more than two dozen are in other stages of clinical trials.
The Oxford vaccine, to be manufactured through the Serum Institute of India, was also approved for Phase 2 and 3 clinical trials that would begin within a week at 17 sites in India. (With PTI inputs)
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