Johnson & Johnson on Monday said its Covid-19 vaccine trial has been temporarily paused due to an ‘unexplained illness’ in one of its participants.
“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.
Jake Sargent, a spokesman for the New Brunswick, New Jersey company, confirmed an earlier report by health-care news provider STAT that the study was paused.
The participant’s illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company’s clinical and safety physicians, the company said in a statement.
News of the Johnson & Johnson Covid vaccine halt comes after AstraZeneca Plc temporarily stopped tests of its vaccine after a trial participant fell ill. However, later the study was resumed in a number of countries, except U.S.
The J&J Phase 3 trial had started recruiting participants in late September. The company has since begun dosing up to 60,000 volunteers, marking the first big trial of a Covid-19 inoculation that may work after just one shot. The vaccine trial pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.