Johnson & Johnson has announced that it has paused the clinical trial of a Covid-19 vaccine because one of the test subjects has developed an unexplained illness presumably related to the test medication, StatNews, a project of Boston Globe Media, reports.
J&J sent an official letter invoking a “pausing rule” to the clinicians working with 60,000 volunteers on the clinical trial of the vaccine. The company has stopped enrolling new test subjects, and it will convene an independent monitoring board to review study findings to date.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement.
A study pause is a typical action when an unexpected outcome happens to a test subject, and occurs frequently during clinical trials. The monitoring board, called a data and safety monitoring board, can last days as it determines the unusual health of the individual. It is not known at this point whether the subject was taking the drug or a placebo.
Should long-term and frequent problems stem from a clinical trial, the program would go into a “clinical trial” which can last months or even result in the halt of the trial.