The company declined to reveal any more details about the illness, citing the participant's
privacy.
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 socalled
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 pause is at least the second such hold to occur among several vaccines that have reached
large-scale final tests in the US.
The company declined to reveal any more details about the illness, citing the participant's
privacy.
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.
https://www.tribuneindia.com/news/health/second-covid-vaccine-trial-paused-overunexplained-
illness-155100
