New Brunswick-based Johnson & Johnson halts COVID-19 vaccine trial after unexpected illness
A late-stage study of
Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the
company probes whether a study participant’s unexplained illness is related to
The New Brunswick-based company
announced in a statement Monday evening that illnesses, accidents and other
so-called adverse events are an expected part of large clinical studies.
In a statement, the company
says, in part, "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, as well as our internal clinical and safety physicians."
Its physicians and a safety
monitoring panel will try to determine what might have caused the illness. The
company did not release details or symptoms of the person's illness, and only
said that researchers are evaluating the subject to see if the illness is
related to their medication.
Johnson & Johnson
officials also emphasize that the person who got sick could have been taking
the placebo. But they say that everything is on hold until more information can
The company adds it must respect this participant's privacy and learn
more about the illness, as well as gather all the facts before sharing
The pause is at least the
second such hold to occur among several vaccines that have reached large-scale
final tests in the U.S.
Final-stage testing of a
vaccine made by AstraZeneca and Oxford University remains on hold in the U.S.,
though it has restarted elsewhere.
AP wire services helped
contribute to this report.