An undisclosed ailment in a study participant has led to the pause of the study of Johnson & Johnson’s Covid-19 vaccine.
A document obtained by STAT revealed that the “pausing rule” has been met, which subsequently leads to the closure of online enrollment system for patients and the convening of data and safety monitoring board.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
Citing the reasons behind the latest development in the study of the vaccine, according to a report by CNBC, the firm, J&J disclosed that the study was paused due to an unexpected illness in a study participant. They declined to expatriate on the point.
The firm was quoted saying: “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
What this means: Clinical trial pauses are a common phenomenon and in some cases, last only a few days. Therefore, there is a need to distinguish between a study pause and a clinical hold. The recent development is a case of study pause and not under a clinical hold. Buttressing this, J&J remarked that why it normally communicates clinical holds to the public, it does not usually inform the public of study pauses, hence the reason why it chose to be taciturn in explaining in detail the motive behind it recent pause.
Backstory: Johnson and Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.