The multinational Johnson & Johnson announced on Monday that it has stopped trials of an investigational vaccine against COVID-19 due to a “unexplained illness” on a participant.
“We have temporarily stopped the administration of new doses in all our clinical trials of the COVID-19 candidate vaccine, including phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant, “the firm said in a statement.
The US company confirmed that “the participant’s disease is being reviewed and evaluated by the Data Security Surveillance Board (DSMB) independent of ENSEMBLE”, as well as by his doctors.
The drugmaker declined to provide further details, 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, based in New Brunswick (New Jersey), underlined the “significant distinction between a study pause and a regulatory retention of a clinical trial.”
“A study pause, in which the study sponsor pauses recruitment or dosing, is a standard component of a clinical trial protocol,” he explained. Johnson & Johnson.
Meanwhile, he added, that the “regulatory retention of a clinical trial is a requirement of a regulatory health authority, such as the US Food and Drug Administration (FDA).”
Last September 23, the US National Institutes of Health (NIH) announced that it had begun recruiting adult volunteers for a fourth Phase 3 clinical trial evaluating an investigational vaccine against COVID-19.
The trial, designed to assess whether the vaccine Janssen COVID-19 In Research (JNJ-78436725) can prevent symptomatic COVID-19 after a single-dose regimen, it sought to enroll up to 60,000 volunteers at around 215 clinical research sites, both nationally and internationally.
Pharmaceutical companies Janssen Johnson & Johnson 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 peak protein of the SARS-CoV-2 in cells.