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Johnson & Johnson pauses Covid-19 vaccine trial after 'unexplained illness'
CNN Profiles - Maggie Fox - Senior editor - CNN
By Maggie Fox, CNN
Updated 9:31 PM ET, Mon October 12, 2020
Johnson & Johnson pauses Covid-19 vaccine trial after 'unexplained illness'
Johnson&Johnson said its Janssen arm had paused its coronavirus vaccine trial after an "unexplained illness" in one of the volunteers testing its experimental Covid-19 shot.
1 hr 4 min agoJohnson & Johnson pauses coronavirus vaccine trial due to "unexplained illness" in volunteer
From CNN's Maggie Fox
Drugmaker Johnson & Johnson said Monday it was pausing the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.
“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies," said the statement.
It’s the second Phase 3 coronavirus vaccine trial to be paused. AstraZeneca’s vaccine trial was paused last month because of an a neurological complication in a volunteer in the UK. While the trial resumed there and in other countries, it remains paused in the United States while the US Food and Drug Administration investigates.
CNN Profiles - Maggie Fox - Senior editor - CNN
By Maggie Fox, CNN
Updated 9:31 PM ET, Mon October 12, 2020
Johnson & Johnson pauses Covid-19 vaccine trial after 'unexplained illness'
Johnson&Johnson said its Janssen arm had paused its coronavirus vaccine trial after an "unexplained illness" in one of the volunteers testing its experimental Covid-19 shot.
1 hr 4 min agoJohnson & Johnson pauses coronavirus vaccine trial due to "unexplained illness" in volunteer
From CNN's Maggie Fox
Drugmaker Johnson & Johnson said Monday it was pausing the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.
ENSEMBLE is the name of the study.“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the company said in a statement.
“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies," said the statement.
It’s the second Phase 3 coronavirus vaccine trial to be paused. AstraZeneca’s vaccine trial was paused last month because of an a neurological complication in a volunteer in the UK. While the trial resumed there and in other countries, it remains paused in the United States while the US Food and Drug Administration investigates.
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