Sunday, November 1, 2020

J&J halts vaccine trials after participant’s ‘sudden sickness’

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Global pharmaceutical big Johnson & Johnson has quickly halted a late-stage trial of its COVID-19 vaccinate candidate, after an “unexplained illness in a study participant.” “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the corporate stated in a press release on Monday. 
J&J stated that such short-term halts attributable to “adverse events – illnesses, accidents, etc,” are quite common, particularly in massive trials, including that the research carried out by the J&J subsidiary have prespecified tips which foresee the pause of research “if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.”
While J&J launched Phase three medical trial for its COVID-19 vaccine candidate final month, with plans to enrol as much as 60,000 volunteers throughout three continents for the examine, it’s unclear how lengthy the pause will final. 
Last week the European Commission introduced it had signed a take care of J&J, in order that its subsidiary Janssen Pharmaceutica NV may provide the EU with as much as 400 million doses of its COVID-19 vaccine.
Once the vaccine will get the green-light by regulators, the American pharmaceutical may allocate 200 million doses of the potential vaccine, ranging from mid-2021, with the chance to safe a further 200 million doses. 
J&J shouldn’t be the primary drug maker to pause medical trials of a possible vaccine for Coronavirus, as in September, AstraZeneca paused the worldwide trials of the Oxford-developed vaccine candidate due to an unexplained sickness in one of many volunteers.

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