Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials
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- A?study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol. As noted in the ENSEMBLE?study protocol, Johnson & Johnson has robust mechanisms in place to protect the safety of participants in its clinical trials. While the Company informs all study investigators, we typically do not communicate study pauses publicly.
- A?regulatory hold?of a clinical trial is a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration (FDA). As outlined in our?transparency commitments, we proactively disclose any regulatory hold of a pivotal clinical trial.