By The Associated Press undefined
NEW BRUNSWICK, N.J. — Johnson & Johnson executives say it will be a few days before they know more about an unexplained illness in one participant that caused a temporary pause in its late-stage COVID-19 vaccine study.
“It may have nothing to do with the vaccine,” Mathai Mammen, head of research and development for Janssen, Johnson & Johnson’s medicine development business, said Tuesday.
Mammen says they don’t yet know whether the ill study participant received their experimental vaccine or a dummy shot. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. It will recommend next steps.
The study of the one-dose vaccine called ENSEMBLE will include up to 60,000 people from multiple countries. The company expects to complete enrollment in the study in two or three months.
Johnson & Johnson isn’t disclosing the nature of the illness, which it learned of Sunday and disclosed Monday night. Such pauses are not uncommon in long clinical studies, as some participants come down with an unrelated illness.
Unlike a study hold imposed by government regulators, a pause is initiated by the sponsor of the drug trial and often can be quickly resolved.