Update, Oct. 13: Johnson & Johnson announced that it has paused all of its COVID-19 vaccine candidate clinical trials, including a large-scale Phase 3 human trial called “Ensemble” that began in September and aimed to enroll up to 60,000 people across three continents. One of the participants in that trial had an “unexplained illness,” the company said.
The Phase 3 clinical trial was in the process of comparing the efficacy of a single-dose vaccine versus a placebo. A company statement explained that the participant’s illness is currently being reviewed, and no other information has been released about the participant’s condition out of privacy. “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” the company wrote. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”