The whole world is patiently waiting for a viable coronavirus vaccine and treatment that could help ease the global crisis in which we all are.
It’s been just reported that drugmaker Johnson & Johnson said this Monday that they had paused the advanced clinical trial of the experimental coronavirus vaccine due to an unexplained illness that appeared 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. CNN notes that ENSEMBLE is the name of the study.
Potential dangerous side effects
“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.
The company’s Janssen arm is the one that is developing the vaccine. The company did not mention what exactly this unexpected illness was, but it’s already a known fact that one of the points of clinical trials in vaccines is to find out potential dangerous side effects.
When such adverse effects pop up, trials take a break, and doctors are checking to see if the illness can be linked to the vaccine or it’s a coincidence.
All clinical studies have prespecified guidelines
“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 as quoted by CNN.
“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 company added.