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Update (October 27): After the company did not find a cause for the participant’ s illness, Johnson & Johnson announced on October 23 that it is seeking to resume the clinical trial, according to a statement.
Johnson & Johnson’s Janssen subsidiary, one of several companies in Phase 3 testing of vaccines to prevent SARS-CoV-2 infection, has temporarily suspended enrollment and dosing in all of its clinical trials after a patient experienced an adverse reaction during its Phase 3 ENSEMBLE trial.
The incident was first reported on Monday (October 12) by STAT after reporters received a copy of a document sent to outside researchers running the study’s individual trials. The document states that a “pausing rule” had been met to justify the suspension and that the online system used to enroll patients was closed.
“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical ...