Johnson & Johnson, a pharmaceutical company announced on October 12, 2020, that it decided to pause the advance clinical trial, ENSEMBLE, of one of its vaccine. The step was taken by the company after an unexplained illness was found in one of the volunteers of the clinical trial.
According to the statement released by the company, following the guidelines, the illness in the participant is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB), as well as the internal safety and clinical physicians of the company.
ENSEMBLE is the name of the study and the injection is being developed by the Janssen vaccine arm of Johnson & Johnson to fight the ongoing pandemic. The clinical trial by the company is also one of the biggest trials with 60,000 people.
While providing the clarification, the pharmaceutical company added that any form of adverse events such as accidents, illness, etc. even if they are serious, is expected in any form of a clinical study, especially if it involves a large number of participants.
The company also talked about its strong commitment to safety and added that al the clinical trials that have been carried out by the Janssen Pharmaceutical Company have prespecified guidelines which state that studies must be paused in case a serious adverse event (SAE) is noticed in relation to the vaccine so that all the medical information can be carefully reviewed.