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A late-stage study of Johnson & Johnson’s Covid-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the injection.
The company said in a statement Monday night (local time) that illnesses, accidents and other so-called adverse events “are an expected part of any clinical trial, especially large studies,” but that its doctors and a panel of Safety monitoring would attempt to determine what may have caused the disease.
Cheryl Gerber / AP
A late-stage study of Johnson & Johnson’s Covid-19 vaccine candidate has been halted while the company investigates whether the “unexplained illness” of a study participant is related to the trial.
The pause is at least the second of its kind to occur among several vaccines that have reached full-scale final testing in the US.
The company declined to disclose further details about the disease, citing the participant’s privacy.
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Temporary stoppages of large medical studies are relatively common.
Few are made public in typical drug trials, but work to make a coronavirus vaccine has raised the stakes on these types of complications.
Companies should investigate any serious or unexpected reactions that occur during drug testing.
Since these tests are performed 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 determining whether the person received the vaccine or a placebo.
Kirsty Wigglesworth / AP
The hiatus is at least the second of its kind to occur among several Covid-19 vaccines that have reached final full-scale testing in the US (File photo).
The halt was first reported by the health news site STAT.
The final stage test of a vaccine made by AstraZeneca and the University of Oxford remains on hold in the US as officials examine whether a disease in their test 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 said. Testing of that company has been restarted elsewhere.
Johnson & Johnson aimed to enroll 60,000 volunteers to demonstrate whether its single-dose approach is safe and protects against coronavirus. Other candidate vaccines in the US require two shots.
