Johnson & Johnson’s COVID-19 vaccine trials “paused” due to “unexplained Johnson & Johnson announced Monday that it has “temporarily paused” further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial due to an “unexplained illness in a study participant.”
“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. It added, “based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have pre-specified guidelines.”
“These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” it affirmed. This comes after AstraZeneca also paused last month its global trials due to a “potentially unexplained illness.”