Johnson & Johnson paused its coronavirus vaccine research study due to an adverse reaction by one of the participants and would not provide further comment on the issue.
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The 60,000-patient clinical trial was shut down in line with the “pausing rule,” and the online patient enrolling system was closed as well, the company disclosed.
“We must respect this participant’s privacy," J&J said in a statement. "We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information."
The big pharma giant also stressed, "illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study."
Though the vaccine study is reportedly not under a clinical hold, there will be a delay in the process as the matter is looked into.
A source familiar with the study told STAT News, which was first to report the development, that these pauses are commonplace, especially when dealing with such a large sample size comprised of tens of thousands of people.
“If we do a study of 60,000 people, that is a small village,” STAT reported. “In a small village, there are a lot of medical events that happen.”
Johnson & Johnson began enrolling volunteers in the Phase 3 study on Sept. 23.