COVID-19 vaccine trial 'temporarily paused' by Johnson & Johnson after 'unexplained illness'

October 13, 2020

    Johnson & Johnson announced on Monday night that it had "temporarily paused" trials of a COVID-19 vaccine after a trial volunteer came down with an "unexplained illness."

    The drugmaker said in a statement, "We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians."

    Johnson & Johnson did not elaborate about the volunteer nor the nature of the illness.

    The company argued in the statement, "Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies."

    It continued, "SAEs (serious adverse events) are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants."

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