Late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot.
FILE - This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. , the company announced Monday, Oct. 12, 2020. The company 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,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
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. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S.
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