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The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.
On Oct. 12, 2020, Johnson & Johnson (J&J) announced that it is temporarily pausing clinical trials, including a Phase III trial (Ensemble), for its COVID-19 vaccine candidate because a study participant developed an unexplained illness.
Currently, the patient’s illness is being reviewed and evaluated by the Ensemble trial’s independent data dafety monitoring board as well as internal clinical and safety physicians, a company press release said.
“Adverse events—illnesses, accidents, etc.—even those that are serious, are an expected part of any clinical study, especially large studies,” J&J stated in the press release. “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 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.”
Source: Johnson & Johnson