Johnson & Johnson COVID-19 Vaccine Trial Stops After Unknown Illness In Volunteer

With COVID-19 continuing to wreak havoc on our lives, vaccine makers around the world are going full speed ahead with their trials.?

Some vaccines have even entered the final stages of their human trials and one of them is leading pharmaceutical giant, Johnson & Johnson.?

Reuters

However, now a Reuters report has revealed that the aforementioned US drugmaker has paused his clinical trials after a volunteer experienced an unexplained illness during the Phase III trials.

Johnson & Johnson issued a formal statement surrounding this, stating, “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.”?

They further added, “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.”

This occurrence is rather surprising as just last month, the pharmaceutical company had revealed that its COVID-19 vaccine had shown a promising immune response against the novel coronavirus in the early-mid stage clinical trials. Only after receiving the promising results, they proceeded with a clinical trial involving 60,000 individuals.?

Johnson & Johnson haven’t revealed details about the ill volunteer in order to respect his privacy, stating, “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.”

Reuters

They’ve also expressed that such advancements in a vaccine trial are common, “Adverse events illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies.” They’ve also revealed that even though the trial has been paused as of now, the situation is very different from a regulatory hold.

Last month, we saw the Oxford-AstraZeneca vaccine trial halted due to unexpected side effects in one of the volunteers. However, the volunteer eventually recovered and the trial was rebooted.?