Johnson & Johnson’s has paused a later stage COVID-19 vaccine as a result of an “unexplained illness” of a participant while the company investigates whether the illness is related to the shot.
The company said this in a statement on Monday evening that illnesses, accidents “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 declined to reveal any more details about the illness, citing the participant’s privacy.
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. 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 US as officials run their investigations whether an illness in its trial poses a safety risk.
That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said.
Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus.