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Johnson & Johnson pauses Covid-19 vaccine trial after 'unexplained illness'

October 13, 2020. Summarized by summa-bot.

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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.

(CNN)Drugmaker Johnson & Johnson said Monday it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.

"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.

The company did not say what the unexplained illness was, but one point of clinical trials is to find out if vaccines cause dangerous side effects.

Trials are stopped when they pop up while doctors check to see if the illness can be linked to the vaccine or is a coincidence.

"Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines.

These ensure our studies may be paused 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," the company said.

"Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants.

Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo. "

The drugmaker said there is a "significant distinction" between a study pause and a regulatory hold on a clinical trial.

"A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol," Johnson & Johnson said.

"A regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the U. S. Food and Drug Administration.

As outlined in our transparency commitments, we proactively disclose any regulatory hold of a pivotal clinical trial. "

This is the second Phase 3 coronavirus vaccine trial to be paused in the US.

AstraZeneca's vaccine trial was paused last month because of a neurological complication in a volunteer in Britain.

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