“Unexplained Illness’ in one patient leads to halt
On Monday, Johnson & Johnson announced they would be temporarily pausing dosing in all COVID-19 vaccine trials, including their Phase III ENSEMBLE trial, due to an unexplained illness in a participant.
Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies. Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our 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.
The company was quick to point out the difference between a study pause, which J&J implemented in this case, and a regulatory hold.
- 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.
Intended to yield results in early 2021, the Johnson & Johnson trial is one of four currently in Phase 3 in the United States. While six coronavirus vaccines are currently in testing in the U.S., the Johnson & Johnson vaccine was notable in that it would require only one dose.
SOURCE: Johnson & Johnson, The Guardian