Johnson & Johnson said Monday it experienced temporarily halted its Covid-19 vaccine trial because one particular of its individuals had grow to be sick.
“We have temporarily paused additional dosing in all our Covid-19 vaccine prospect clinical trials, which includes the Period 3 ENSEMBLE trial, due to an unexplained disease in a analyze participant,” the organization claimed in a assertion.
The pause suggests the on-line enrollment method has been shut for the 60,000-individual medical trial although the unbiased client protection committee is convened.
J&J stated that significant adverse situations (SAEs) are “an anticipated portion of any clinical review, in particular huge studies.” Organization rules authorized them to pause a study to ascertain if the SAE was relevant to the drug in concern and whether to resume research.
The J&J Stage 3 trial had commenced recruiting members in late September, with a intention of enrolling up to 60,000 volunteers across a lot more than 200 sites in the US and around the planet.
The other nations around the world where by the trials ended up using spot are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
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