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“We have temporarily suspended additional dosing in all clinical trials of our COVID-19 candidate vaccine, including the ENSEMBLE phase III trial, due to unexplained illness in a study participant,” the company said in a statement.
A pause means that the registration system for study participants has been temporarily closed and an independent patient safety committee is being convened.
Johnson & Johnson emphasized that serious adverse events, such as accidents or illness, are “an expected part of any clinical trial, especially a large trial.”
Company guidelines allow you to suspend the study to determine if these events are related to the study product and if the study can continue.
Participants in the Johnson & Johnson vaccine phase III clinical trials began enrolling in late September to enroll up to 60,000 people. volunteers at more than 200 locations in the US and around the world, reported the company and the US National Institutes of Health (NIH), which provides funding.
The company became the 10th manufacturer globally to launch a phase III study of the COVID-19 vaccine, and the fourth in the United States.
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