Johnson & Johnson has paused a trial for a COVID-19 vaccine after a participant developed an “unexplained illness.”
Lydia Ramsay Pflanzer reported for the Business Insider:
Johnson & Johnson said Monday that it had temporarily halted its coronavirus vaccine trials after a participant experienced an unexplained illness, the second major setback to hit a late-stage test of a coronavirus immunization.
The pharma giant said it paused all further dosing in the trials after a participant fell ill. The pause in the trial, which is aiming to enroll 60,000 people to determine if the vaccine is safe and effective, was first reported by Stat News’ Matthew Herper.
Elizabeth Weise and Karen Weintraub from US Today wrote:
In any study the size of the Johnson & Johnson one, which will include up to 60,000 people when it is fully enrolled, some adverse events are expected among the participants. Such studies have clear, prespecified guidelines that say what events would trigger a shutdown.
The independent Data Safety Monitoring Board, which oversees the trial, will review what happened and decide whether it is safe to resume the trial.
CNN’s Maggie Fox quoted the company:
“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 said.
