NEW BRUNSWICK, KOMPAS.com - A Covid-19 vaccine trial by Johnson & Johnson has been paused after a study participant incurred an “unexplained illness”.
The late-stage study of the Covid-19 vaccine gives the company time to investigate whether the participant’s illness is related to the shot.
Johnson & Johnson said in a statement Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies”.
Nonetheless, its physicians and a safety monitoring panel would try to determine what might have caused the illness.
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Johnson & Johnson’s abrupt halt of its Covid-19 vaccine trial is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the US.
The company declined to reveal any more details about the illness, citing the participant’s privacy.
Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
Companies are required to investigate any serious or unexpected reaction that occurs during drug testing.
Given that such tests are done on tens of thousands of people, some medical problems are a coincidence.