Johnson & Johnson mentioned Monday it had briefly halted its Covid-19 vaccine trial as a result of considered one of its members had turn into sick.
“Now we have briefly paused additional dosing in all our Covid-19 vaccine candidate scientific trials, together with the Part three ENSEMBLE trial, on account of an unexplained sickness in a examine participant,” the corporate mentioned in a press release.
The pause means the web enrollment system has been closed for the 60,000-patient scientific trial whereas the unbiased affected person security committee is convened.
J&J mentioned that critical hostile occasions (SAEs) are “an anticipated a part of any scientific examine, particularly giant research.” Firm pointers allowed them to pause a examine to find out if the SAE was associated to the drug in query and whether or not to renew examine.
The J&J Part three trial had began recruiting members in late September, with a purpose of enrolling as much as 60,000 volunteers throughout greater than 200 websites within the US and world wide.
The opposite international locations the place the trials have been going down are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
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