Drugmaker Johnson & Johnson has decided to pause the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.
In a statement, the company said: “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.
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As CNN notes, 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,” the company explained.
No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence.
As of right now, it’s also not clear if the volunteer had received the vaccine or the placebo.
It was previously reported that the Johnson & Johnson phase 3 trial of its Janssen COVID-19 vaccine included 60,000 adults in multiple countries, testing the safety and efficacy of a single dose versus a placebo. A two-dose regimen is being tested in a separate trial.
This latest pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S., the news site notes.