2nd COVID-19 vaccine trial paused over unexplained illness

NEW BRUNSWICK, N.J. (AP) - A late-stage study of Johnson & Johnson's COVID-19 vaccine candidate was paused while the company investigates whether a study participant's “unexplained disease” was related to the shot.
The company said in a statement Monday evening that illness, accidents and other so-called adverse events "are an expected part of any clinical trial, especially large trials," but that its doctors and a safety oversight panel would try to determine what possibly caused the disease .
The hiatus is at least the second such hiatus to occur with several vaccines that have passed extensive final testing in the US.
The company declined to reveal more details about the disease, citing the participant's privacy.
Temporary interruptions in large medical studies are relatively common. Few are published in typical drug studies, but work on making a coronavirus vaccine has increased the use of these types of complications.
Companies must investigate any serious or unexpected reactions that occur during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are accidental. In fact, one of the first steps the company announced is to determine if the person received the vaccine or a placebo.
The stop was first reported by health news site STAT.
Trials of a terminal vaccine manufactured by AstraZeneca and Oxford University remain on hold in the U.S. as officials assess whether a disease is a safety risk in their study. This study was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord. This company's tests were restarted elsewhere.
Johnson & Johnson wanted to enroll 60,000 volunteers to prove that its single-dose approach was safe and protects against the coronavirus. Other vaccine candidates in the US require two shots.

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