Johnson & Johnson announced it has paused the clinical trials for its COVID-19 vaccine after one of the participants developed an unexplained illness. The pharmaceutical company did not disclose the illness and said the ENSEMBLE independent Data Safety Monitoring Board is reviewing the patient's condition.
"Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies. Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines," the company said in a statement. "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."
This is the second time that a clinical trial for a COVID-19 vaccine candidate has been paused in the United States due to a participant developing an unexpected illness. Last month, AstraZeneca paused their study after one of the participants developed a spinal inflammatory disorder. The trials have resumed in the United Kingdom, but the company is still waiting for approval from the Food and Drug Administration to restart the tests in the United States.
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