(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.
Buddhatechnology on October 13rd, 2020 at 03:17 UTC »
Anyone who knows how drug development and clinical trials work will tell you this is common and not to be alarmed. It's standard procedure and could be completely unrelated. Keep in mind these trials have 10's of thousands of participants and every possible side effect regardless how insignificant is reported.
With such big patient numbers, there's bound to be participants who develop a significant illness for whatever reason.
readzalot1 on October 13rd, 2020 at 03:16 UTC »
Remember Thalidomide in the 1950s/60s - the head of the FDA in the US did not approve the drug, despite heavy political and corporate pressure. Canada, Australia, and much of Europe approved it and hundreds of babies were born with serious disabilities.
MijnnaamiFbeeFt on October 13rd, 2020 at 01:47 UTC »
It’s good to take vaccine development seriously. We need a solid, dependable, effective vaccine for this, not something that’s rushed through under political pressure.