Johnson & Johnson image shows a single-dose Covid-19 vaccine being developed by the company. Photo / AP
Johnson & Johnson image shows a single-dose Covid-19 vaccine being developed by the company. Photo / AP
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 shot.
The company said in a statement on Monday evening that illnesses, accidents and other so-called adverse events "are an expected part ofany clinical study, especially large studies," but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
"Following our guidelines, the participant's illness is being reviewed and evaluated by the Ensemble independent Data Safety Monitoring Board as well as our internal clinical and safety physicians," Johnson & Johnson said.
The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the US.
The pause includes phase three of its Janssen Pharmaceutical Companies trial called "Ensemble", involving up to 60,000 volunteers across three continents.
The company declined to reveal any more details about the illness, citing the participant's privacy.
Johnson & Johnson last week sealed a deal with the European Union for 200 million doses of its vaccine "following approval or authorisation from regulators", with the option of another 200 million doses.
Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
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. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.
The halt was first reported by the health news site STAT.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the US 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.
Johnson & Johnson was aiming to enrol 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the US require two shots.
