Johnson & Johnson started a clinical trial of its experimental coronavirus vaccine. However, recently they have stopped it because of an unexplained illness that occurred to one of the volunteers.
The company stated: “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. Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
The Janssen vaccine is currently under development. The company could not explain what the illness was, but they are searching to see if vaccines cause side effects. Doctors are currently checking to see if the illness is linked to the vaccine or not.
All the information is carefully reviewed
All of the clinical studies that were conducted by Johnson & Johnson have followed some guidelines. They all ensure that the studies may be put on pause if an SAE – a serious adverse event – is happening, and it is related to the vaccine or the clinical study itself. Before resuming the study, all of the medical information needs to be carefully reviewed.
The privacy of all the participants is respected. Before sharing further information, they need to learn more about the illness.
SAE is not a problem
SAE – serious adverse events are quite common in clinical trials. They are actually expected to appear in trials with a large number of participants. Many of these trials are using placebo, so they cannot immediately say if a participant received treatment or simply received a placebo.