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Pharma.com, Oct. 14 (Xinhua) -- Johnson and Johnson Announced Tuesday that it has decided to suspend clinical trials of a new crown-candidate vaccine developed by its Janssen Pharmaceuticals Inc. because of an "unseplained illness" in one of its subjects.
said in a statement the same day that it will suspend all clinical trials of the vaccine, including Phase 3 clinical trials that started at the end of September.
, an independent commission and experts from Johnson and Johnson are investigating and assessing the subject's condition.
statement, disease, accident and other adverse events are possible in any clinical study, especially large-scale clinical studies.
all clinical studies conducted by Janssen Pharmaceuticals have pre-set guidelines to ensure that the study can be suspended once an unexpected serious adverse event associated with a vaccine or drug has been detected, pending an investigation before deciding whether to restart the study.
said in a statement that serious adverse events are not uncommon in clinical trials, and that in clinical trials involving a large number of participants, it is reasonable to expect an increase in serious adverse events.
addition, since many clinical trials are randomized double-blind controlled trials, it is often not immediately clear whether the subjects received experimental treatment or a placebo.
The new crown candidate vaccine, a recombinated adenovirus vector vaccine, was launched on September 23rd and plans to recruit about 60,000 adult volunteers worldwide in about 215 locations in the United States and other parts of the world.
the vaccine is the fourth new crown-candidate vaccine to be tested in Phase 3 clinical trials in the United States, with volunteers requiring two doses of the first three vaccines, while the vaccine is a single dose.
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