U.S. drug maker Johnson & Johnson on Monday said its advanced clinical trial of an experimental COVID-19 vaccine has been paused because of an unexplained illness in one of the study volunteers.
"… our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine."
From STAT news:
A document sent to outside researchers running the 60,000-patient clinical trial states that a "pausing rule" has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.
Contacted by STAT, J&J confirmed the study pause, saying it was due to "an unexplained illness in a study participant." The company declined to provide further details.
"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 company said in a statement.