The multinational Johnson & Johnson announced this Monday that stopped its vaccine trials in investigation against Covid-19 due to a “unexplained illness” in one 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 US company confirmed that “the participant’s illness is being reviewed and evaluated by the Data Security Monitoring Board (DSMB) independent of ENSEMBLE “, as well as by its doctors.
The pharmaceutical company declined to provide further details by arguing that they must “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 firm also underlined the “significant distinction between a study pause and a regulatory retention of a clinical trial”As “a study pause, in which the study sponsor pauses recruitment or dosing, is a standard component of a clinical trial protocol.”
Also, the company considers that the “regulatory retention of a clinical trial is a requirement of a regulatory health authority, such as the Food and Drug Administration of the United States (FDA).”
Chile is one of the countries where it would be tested
On September 23, the United States National Institutes of Health (NIH) announced that the recruiting adult volunteers to a fourth Phase 3 clinical trial evaluating an investigational vaccine against Covid-19.
The trial, designed to evaluate if Janssen Covid-19 Vaccine Under Investigation (JNJ-78436725) can prevent symptomatic Covid-19 after a single dose regimen, sought to enroll up to 60 thousand volunteers in around 215 clinical research sites, both national and international, including Chile, whose tests would be led by the University of Chile.
Johnson & Johnson’s Janssen pharmaceutical companies developed the investigational vaccine and lead the clinical trial as a regulatory sponsor.
Janssen’s candidate vaccine is a recombinant vector that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.