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American Johnson & Johnson said Monday that it temporarily halted its clinical trial of the COVID-19 vaccine because one of its participants became ill. “We have temporarily halted the administration of new doses in all of our clinical trials of the COVID-19 vaccine, including the phase 3 ENSEMBLE trial, due to unexplained illness in one study participant.”the company said in a statement.
The hiatus means the online enrollment system has been shut down for the 60,000-patient clinical trial, while the independent patient safety committee is convened..
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The company assured that “adverse events (illnesses, accidents, etc.), even those that are serious, are an expected part of any clinical study, especially large studies.”
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 New Brunswick, New Jersey-based firm underscored the “significant distinction between a study break and a regulatory retention of 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 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 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 are leading 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.
TRIAL IN COLOMBIA
Last Wednesday, October 7, the first experimental vaccine, from Johnson & Johnson, against the coronavirus was applied in Colombia at the El Bosque headquarters of the Cardiovascular Foundation, in Bucaramanga.
After the first dose, another 16 people received the vaccine with which a new phase of experimentation began in the clinical trial of the Johnson & Johnson vaccine.
The first Colombian volunteer to receive the experimental vaccine would have been a man in his 50s, who enrolled in the program. Those who are part of the clinical study will have a medical follow-up for two years.
The Minister of Health, Fernando Ruiz, confirmed the trial during the ‘Prevention and Action’ program the night before. “Faced with the clinical trials of the Covid19 vaccine, in which Colombia participates, this Wednesday the first dose will be applied to the first volunteer linked to said process,” said Minister Ruiz.
AFP
