Trial was paused resulting from “unexplained sickness in a research participant”, the agency mentioned (Representational)
Washington, United States:
Johnson & Johnson mentioned Monday it had briefly halted its Covid-19 vaccine trial as a result of one among its members had develop into sick.
“We now have briefly paused additional dosing in all our Covid-19 vaccine candidate medical trials, together with the Section three ENSEMBLE trial, resulting from an unexplained sickness in a research participant,” the corporate mentioned in a press release.
The pause means the web enrollment system has been closed for the 60,000-patient medical trial whereas the impartial affected person security committee is convened.
J&J mentioned that severe adversarial occasions (SAEs) are “an anticipated a part of any medical research, particularly giant research.” Firm tips allowed them to pause a research to find out if the SAE was associated to the drug in query and whether or not to renew research.
The J&J Section three 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 all over the world.
The opposite international locations the place the trials had been happening are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa
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