J&J: pauses Covid-19 vaccine trial after unexplained illness

(CercleFinance.com) - Johnson & Johnson said it has temporarily paused further dosing in all its Covid-19 vaccine candidate clinical trials, including its phase-3 study, due to an unexplained illness in a study participant.


The US healthcare giant said the participant's illness is being reviewed and evaluated by an independent data safety monitoring board, as well as its internal clinical and safety physicians.

Unlike a regulatory hold - where a clinical trial is stopped due to a requirement by a regulatory health authority - a study pause means that a trial is paused by the study sponsor to protect the safety of participants.

Adverse events such as illnesses are an expected part of any clinical study, especially large studies, J&J reminded in a statement.

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