Drugmaker Johnson & Johnson said Monday it was pausing the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the company said in a statement.
ENSEMBLE is the name of the study.
“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies," said the statement.
It’s the second Phase 3 coronavirus vaccine trial to be paused. AstraZeneca’s vaccine trial was paused last month because of an a neurological complication in a volunteer in the UK. While the trial resumed there and in other countries, it remains paused in the United States while the US Food and Drug Administration investigates.