Courtesy of CNN:
Drugmaker Johnson & Johnson said Monday it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.
“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. ENSEMBLE is the name of the study.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.” The pause was first reported by Stat News.
Johnson & Johnson’s Janssen vaccine arm is developing the shot. The company did not say what the unexplained illness was, but one point of clinical trials is to find out if vaccines cause dangerous side effects. Trials are stopped when they pop up while doctors check to see if the illness can be linked to the vaccine or is a coincidence.
“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.
Johnson and Johnson were among the pharmaceutical companies that promised not to release a vaccine until it had been tested thoroughly and proven safe.
I am glad to see they are sticking by that promise.
I think this also more or less proves that there will be no vaccine made commercially available before the election, despite promises made by Donald Trump.
Let’s face it if he were in charge of this process he would be mass producing a vaccine that was shown to kill thirty percent of those taking it and writing that off as an acceptable loss.