Johnson & Johnson announced late Monday it is temporarily pausing recruitment and dosing of its coronavirus vaccine in clinical trials due to an “unexplained illness in a study participant.”
The independent drug safety monitoring board for J&J’s phase 3 ENSEMBLE trial is reviewing the unexpected event. The company did not disclose more information about the affected individual.
“We must respect this participant’s privacy,” J&J said in a statement. “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 noted that in placebo-controlled clinical trials, it “is not always immediately apparent” if a given individual received the treatment or a placebo. It also cautioned that adverse events — even serious ones — “are an expected part of any clinical study, especially large studies.”
J&J began its phase three clinical trial last month. There has been considerable interest in this vaccine because it does not have to be frozen, so it’s easier to transport and store.
