J&J 'Paused' COVID-19 Phase 3 Vaccine Study

New Jersey-based Johnson and Johnson (J&J) announced on late October 12, 2020, 'it has temporarily paused further dosing in all Ad26.COV2-S (JNJ-78436735) COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.'

Following J&J guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians. Serious Adverse Events are not uncommon in clinical trials, and the number of events can reasonably be expected to increase in trials involving large numbers of participants, stated J&J.