The multinational Johnson & Johnson announced Monday that it has stopped trials of an investigational vaccine against COVID-19 due to an “unexplained illness” in a participant.
“We have temporarily halted the administration of new doses in all of our clinical trials of the COVID-19 candidate vaccine, including the phase 3 ENSEMBLE trial, due to unexplained illness in a study participant,” the firm said in a statement.
The American company confirmed that “the participant’s illness is being reviewed and evaluated by ENSEMBLE’s independent Data Security Oversight Board (DSMB), “as well as its physicians.
The drugmaker declined to provide further details, arguing that they should “respect the privacy of this participant”.
“We are learning more about the disease from this participant and it is important to have all the data before sharing additional information,” the statement added.
The New Brunswick, NJ-based firm underscored the “significant distinction between a study break and a regulatory hold on a clinical trial.”
“A study hiatus, in which the study sponsor pauses recruitment or dosing, is a standard component of a clinical trial protocol,” explained Johnson & Johnson.
Meanwhile, he added, that the “regulatory retention of a clinical trial is a requirement of a health authority regulatory, such as the US Food and Drug Administration (FDA). “
On September 23, the National Institutes of Health of the United States (NIH, for its acronym in English) announced that recruiting adult volunteers had started for a fourth Phase 3 clinical trial evaluating an investigational COVID-19 vaccine.
The trial, designed to assess whether the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen, sought to enroll up to 60,000 volunteers in around 215 clinical research sites, both national and international.
Johnson & Johnson’s Janssen pharmaceutical companies developed the investigational vaccine and lead the clinical trial as a regulatory sponsor.