Johnson and Johnson paused a late-stage trial of its coronavirus vaccine after a participant developed an unexplained illness.
The company did not provide further details about the illness, but stressed that these kinds of delays are normal in a trial involving tens of thousands of participants. J&J also pointed out that the pause is voluntary and not a “regulatory hold.”
This is the second major coronavirus vaccine stud to be paused. AstraZeneca was also forced to halt its late-stage trial after a woman in the UK who took the vaccine came down with transverse myelitis, which causes inflammation of the spinal cord. Although the AstraZeneca trial has resumed in the UK, South Africa, India and Brazil, it is still on hold in the U.S.
An independent data and safety monitoring board is now reviewing the incident in the J&J trial.
Read the Reuters report.