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. The company did not say what the unexplained illness was. It is also unclear whether the patient received the experimental vaccine or was in the placebo-control group.
The online system used to enroll patients in the study has been closed. J&J emphasized that so-called adverse events – illnesses, accidents, and other bad medical outcomes – are an expected part of a clinical study”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 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. The Johnson & Johnson trial is the biggest trial of the vaccine that I know of , 60,000 people. This is the second Phase 3 coronavirus vaccine trial to be paused in the US after AstraZeneca’s vaccine trial. Johnson’s Phase 3 trial started in September. It’s one of six coronavirus vaccines being tested in the US. It requires just one dose of vaccine.