A late-stage study of Johnson & Johnson’s COVID-19 vaccine  has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot.

 

The company said in a statement yesterday 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.  The company did not reveal any more details about what the illness was, citing the participant’s privacy.

The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S.

Final-stage testing of a vaccine made by AstraZeneca and Oxford University also remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman was reported to have developed severe neurological symptoms consistent with transverse myelitis, a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems. In rare instances, vaccines have triggered cases of transverse myelitis; although it can also be caused by viral infections. That company’s testing has restarted elsewhere but remains on hold in the United States.

Johnson & Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

The J & J vaccine issue was first reported by the health news site STAT which can be seen HERE.

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