Another high-profile Phase 3 vaccine trial has been temporarily halted after one of the participants developed a suspicious illness.
According to a report published Monday night by STAT News, Johnson & Johnson has informed participants and researchers that its 60,000-person trial would be temporarily paused as the company and the Data and Safety Monitoring Board, the organization overseeing all the US COVID-19 trials.
J&J confirmed the pause when contacted by STAT, though it offered no details about the illness or the patient.
Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.”
The company declined to provide further details. “We must respect this participant’s privacy. 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 said in a statement.
According to STAT, the DSMB was convened late Monday evening to start looking into the case. J&J said that in cases like this, “it is not always immediately apparent” whether the participant who experienced an adverse event received the experimental vaccine or a placebo. – READ MORE