Johnson & Johnson Halts Vaccine Trial After Participant Falls Sick

The trial for the Johnson & Johnson COVID-19 vaccine has been temporarily halted after a participant became ill, AFP reported on Tuesday, 13 October. Photo used for representational purposes only.

(Photo: iStock)

The trial for the Johnson & Johnson COVID-19 vaccine has been temporarily halted after a participant became ill, news agency AFP reported on Tuesday, 13 October. The trial was in Phase 3, and had started recruiting participants in late September.

The patient's condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as internal clinical and safety physicians, Xinhua news agency quoted a company statement as saying.

“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,” the company said in a statement.

According to AFP, Johnson and Johnson said that serious adverse effects "an expected part of any clinical study, especially large studies” and their company guidelines allow them to halt an ongoing trial to determine whether the adverse effect is related to the trial and whether the study can be resumed or not.

“Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”

Johnson & Johnson company statement

The pause in the trial means that the independent patient safety committee is being convened and enrollment for the trials has been closed for now.

(With inputs from AFP.)