On Oct. 23, 2020, Johnson & Johnson announced that it was preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the U.S. after a temporary pause. The independent Data Safety and Monitoring Board overseeing the ENSEMBLE study recommended resuming trial recruitment.

After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause was identified. Based on the information gathered to date, the Company found no evidence that the vaccine candidate caused the event.