Pharmaceutical giant Johnson & Johnson announced on Monday that it has paused its coronavirus vaccine trial after a participant developed an “unexplained illness,” CNN reports.
"Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians," the company said in a statement, referring to the name of the trial.
"Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies,” the statement added.
Company won’t say what the illness is:
The company would not comment on what the illness was but said it was not necessarily caused by the vaccine.
"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.
"We must respect this participant's privacy. We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information," the statement added. "Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo."
Pauses are common:
AstraZeneca also had to pause its vaccine trial earlier this year but has since restarted.
"The Johnson & Johnson trial is the biggest trial of the vaccine that I know of -- 60,000 people," Brown University School of Public Health Dean Ashish Jha told CNN. "Within that trial you'd expect a few pauses."
"We want the vaccine to be safe and we've got to let the process play out and it's going to take a while," he added. "To me it's reassuring that companies are acting responsibly and pausing when they need to."
