Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

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The study of Johnson & Johnson‘s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

A doc despatched to outdoors researchers operating the 60,000-patient medical trial states {that a} “pausing rule” has been met, that the web system used to enroll sufferers in the study has been closed, and that the info and security monitoring board — an unbiased committee that watches over the security of sufferers in the medical trial — could be convened. The doc was obtained by STAT.

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Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The firm declined to present additional particulars.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the corporate stated in an announcement.

J&J emphasised that so-called hostile occasions — diseases, accidents, and different dangerous medical outcomes — are an anticipated a part of a medical study, and likewise emphasised the distinction between a study pause and a medical maintain, which is a proper regulatory motion that may final for much longer. The vaccine study is just not at the moment below a medical maintain. J&J stated that whereas it usually communicates medical holds to the general public, it doesn’t normally inform the general public of study pauses.

The information and security monitoring board, or DSMB, convened late Monday to assessment the case. J&J stated that in instances like this “it is not always immediately apparent” whether or not the participant who skilled an hostile occasion obtained a study therapy or a placebo.

Though medical trial pauses usually are not unusual — and in some instances final only some days — they’re producing outsized consideration in the race to take a look at vaccines in opposition to SARS-CoV-2, the virus that causes Covid-19.

Given the scale of Johnson & Johnson’s trial, it is not stunning that study pauses might happen, and one other might occur if this one resolves, a supply conversant in the study stated.

“If we do a study of 60,000 people, that is a small village,” the supply stated. “In a small village there are a lot of medical events that happen.”

On Sept. 8, a big study of one other Covid-19 vaccine being developed by AstraZeneca and Oxford University was placed on maintain due to a suspected hostile response in a affected person in the United Kingdom. It’s believed that the affected person had transverse myelitis, a spinal wire downside. Studies of the vaccine resumed roughly per week after it was paused in the United Kingdom, and have since been restarted in different international locations as effectively. It stays on maintain, nevertheless, in the United States. 

Johnson and Johnson started enrolling volunteers in its Phase 3 study on Sept. 23. Researchers deliberate to enroll 60,000 members in the United States and different international locations.

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