Coronavirus vaccine trial halted after participant gets sick
Johnson & Johnson announced that it had temporarily halted its COVID-19 vaccine trial because one of its participants had become sick.
“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 was quoted by the AFP news agency as saying.
The pause means the enrolment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
J&J said that serious adverse events (SAEs), such as accidents or illnesses, are “an expected part of any clinical study, especially large studies”.
But Dr William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, told the Reuters news agency that “everybody is on the alert” because of what happened with the AstraZeneca, adding that it could take a week to gather information.
“It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack – they wouldn’t stop it for any of those reasons. This is likely to be a neurological event,” he said.
Company guidelines allow them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.