Zydus Cadila's COVID-19 Vaccine Candidate Passes Early-Stage Human Trial
The company will now start a mid-stage trial of the vaccine candidate, ZyCoV-D, in over 1,000 healthy adult volunteers from Thursday to test its effectiveness, it said in a regulatory filing.
India's Zydus Cadila (Cadila Healthcare), an Indian pharmaceutical company, said that its COVID-19 vaccine candidate was found to be safe and well-tolerated in an early-stage human trial, reported Reuters.
Over 1,000 health adult volunteers will be a part of the pharmaceutical company's mid-stage trial of the vaccine candidate, ZyCoV-D from Thursday to test its effectiveness.
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"The Phase I dosing to establish the safety of ZyCoV-D is an important milestone. All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post-dosing for safety and for seven days thereafter and the vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,¡± said Pankaj R Patel, Chairman, Zydus Cadila.
Zydus plans to complete late-stage trials for ZyCoV-D by February or March and could produce up to 100 million doses a year initially, the company's chairman told Reuters last month.
An independent data safety monitoring board administered doses for the safety of the vaccine candidate in volunteers enrolled in the early-stage trial.
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Zydus is also among the several Indian generic drug makers that have licensing agreements with US-based Gilead Sciences to produce Remdesivir, the antiviral that has been approved in the country as an emergency treatment to fight the coronavirus outbreak.
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India reported a daily jump of more than 50,000 COVID-19 infections for the seventh consecutive day on Wednesday. Total cases now stand at 1.91 million, the third biggest, after the United States and Brazil.
