#JNJ "have temporarily paused further dosing in all [their] COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following [their] guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as [ther] 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 [their] strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure [their] 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" (see press release HERE).