Drugmaker Johnson & Johnson on Monday said it has temporarily paused the advanced clinical trial of its experimental Covid-19 vaccine ...
Drugmaker Johnson & Johnson on Monday said it has temporarily paused the advanced clinical trial of its experimental Covid-19 vaccine because of an unexplained illness in one of the volunteers. The Phase 3 trial of its vaccine began last month, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the United States and around the world.
“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,” the company said in a statement.
The company added that illnesses, accidents and other adverse events were 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.
“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 did not reveal...
