10/13/2020 1:03 AM
Clarín.com
Society
Updated 10/13/2020 1:03 AM
The multinational Johnson & Johnson announced on Monday that it
stopped trials
of an investigational vaccine against the coronavirus 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 US company confirmed that "the participant's disease is being reviewed and evaluated by the Data Security Monitoring 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.
Johnson & Johnson halted trials of its possible Covid-19 vaccine, due to the unexplained illness of a participant.
AFP photo
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 regulatory health authority, such as the US Food and Drug Administration (FDA)."
On September 23, the United States National Institutes of Health (NIH) announced that they 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 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 at 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.
The Johnson & Johnson project was recruiting volunteers for the fourth Phase 3 clinical trial of its vaccine.
AP Photo
Janssen's candidate vaccine is a recombinant vector that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.
It is not the first project to be temporarily suspended.
At the beginning of September, AstraZeneca and the Jenner Institute at the University of Oxford announced a pause in their research - in phase 3 - for finding "possible adverse reactions" in a participant in the United Kingdom.
Finally, four days later, AstraZeneca received the approval of the Medicines Health Regulatory Authority and resumed the trials of the vaccine that, if the tests are successful, will be developed in Argentina.
With information from EFE
Look also
Crack in the WHO for the usefulness of quarantines against the coronavirus
Coronavirus in the United States: How to Choose the Right Vaccine and Avoid "Chaos and Confusion"
