Johnson & Johnson on Monday mentioned its Covid-19 vaccine trial has been quickly paused because of an ‘unexplained sickness’ in one in every of its individuals.
“Now we have quickly paused additional dosing in all our Covid-19 vaccine candidate scientific trials, together with the Part three ENSEMBLE trial, because of an unexplained sickness in a research participant,” the corporate mentioned in an announcement.
Jake Sargent, a spokesman for the New Brunswick, New Jersey firm, confirmed an earlier report by health-care information supplier STAT that the research was paused.
The participant’s sickness is being reviewed and evaluated by an impartial knowledge and security monitoring board in addition to the corporate’s scientific and security physicians, the corporate mentioned in an announcement.
Information of the Johnson & Johnson Covid vaccine halt comes after AstraZeneca Plc quickly stopped exams of its vaccine after a trial participant fell unwell. Nonetheless, later the research was resumed in quite a lot of international locations, besides U.S.
The J&J Part three trial had began recruiting individuals in late September. The corporate has since begun dosing as much as 60,000 volunteers, marking the primary large trial of a Covid-19 inoculation that will work after only one shot. The vaccine trial pause means the web enrollment system has been closed for the 60,000-patient scientific trial whereas the impartial affected person security committee is convened.