Trial was paused because of “unexplained sickness in a examine participant”, the agency stated (Representational)
Washington, United States:
Johnson & Johnson stated Monday it had quickly halted its Covid-19 vaccine trial as a result of one among its members had change into sick.
“We have now quickly paused additional dosing in all our Covid-19 vaccine candidate scientific trials, together with the Part 3 ENSEMBLE trial, because of an unexplained sickness in a examine participant,” the corporate stated in an announcement.
The pause means the net enrollment system has been closed for the 60,000-patient scientific trial whereas the impartial affected person security committee is convened.
J&J stated that critical opposed occasions (SAEs) are “an anticipated a part of any scientific examine, particularly massive research.” Firm tips 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 3 trial had began recruiting members in late September, with a aim of enrolling as much as 60,000 volunteers throughout greater than 200 websites within the US and around the globe.
The opposite nations the place the trials had been happening are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa
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