News
Johnson & Johnson temporarily pauses all dosing in Janssen COVID-19 vaccine candidate clinical trials
Johnson & Johnson has temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase III ENSEMBLE trial, due to an unexplained illness in a study participant. Following company guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as internal clinical and safety physicians.
Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies. Based on its strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure its 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.
Johnson & Johnson is currently testing its vaccine candidate in four trials, including a Phase III trial that is enrolling some 60,000 volunteers across the U.S., South Africa and a half dozen South American countries. The participant who became ill appears to have been enrolled in that late-stage study.
Condition: Coronavirus/COVID-19 Infection
Type: drug