Johnson & Johnson pauses coronavirus vaccine trial following ‘unexplained illness’ in participant
No details on the illness were revealed
{{#rendered}} {{/rendered}}Pharmaceutical giant Johnson & Johnson on Monday night announced that it had paused its late-stage COVID-19 vaccine trial after an “unexplained illness” was reported in a participant.
“Adverse events – illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement when announcing the temporary halt.
The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. (iStock)
No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence. It’s also not clear if the volunteer had received the vaccine or the placebo.
{{#rendered}} {{/rendered}}“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company added.
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The pause, which was first reported by the health news site STAT, comes after the company began the Phase 3 trial of its vaccine in September.
{{#rendered}} {{/rendered}}The temporary halt is not the first to occur in the race to find a safe and effective vaccine to protect against COVID-19. In fact, the pause is the second such hold to occur among several vaccine candidates that have reached large-scale final tests in the U.S.
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Final-stage testing of a vaccine made by AstraZeneca and Oxford University 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 developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company's testing has restarted elsewhere.
{{#rendered}} {{/rendered}}Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.
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The Associated Press contributed to this report.