Johnson & Johnson has paused its late stage clinical trials for a COVID-19 vaccine because of an “unexplained” illness in one of the participants, the company said Monday.
It said in a news release that the trial was paused while the study’s independent Data Safety Monitoring Board conducted a review and evaluation of the participant’s condition.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
The company noted the “significant distinction” between a study pause and a regulatory hold, explaining that a pause is not unexpected in vaccine trials.
“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the statement said.
Johnson & Johnson’s coronavirus vaccine became the fourth to begin Phase 3 trials in the United States last month and