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The results of the company’s experience were expected to be announced before the end of this year or early 2021.
Johnson & Johnson said Monday that it had temporarily suspended clinical trials of the Covid-19 vaccine after a study volunteer fell ill with an unexplained illness, disrupting one of the largest efforts to contain the global epidemic.
The company said in a statement that the volunteer’s illness is subject to review and evaluation by an independent committee to monitor data and safety, as well as company doctors and safety doctors.
Johnson & Johnson, which announced quarterly financial results Tuesday morning, added that such a temporary suspension is normal for large trials, which could include tens of thousands of people, and said that the “suspension of the study”, Regarding the administration of the expected vaccine doses, it differs from the “regulatory suspension” required by the health authorities.
Johnson & Johnson’s move comes after a similar procedure carried out by the company “AstraZeneca” last September, which previously suspended trials of the later stages of its experimental vaccine for the coronavirus, which was developed in cooperation with the University of Oxford, due to an unexplained illness of a volunteer in the British study.
Although trials have resumed in Britain, Brazil, South Africa and India, trials in the United States are still pending due to regulatory review.
“Everyone is on the alert for what happened with AstraZeneca,” William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine, said by email, adding that it could take a week to collect the information.
He said, “It must be something very harmful. If it’s something like prostate cancer or uncontrolled diabetes or a heart attack, they won’t stop the study for any of these reasons, this is likely nerve related.”
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The company said in a statement that the volunteer’s illness is subject to review and evaluation by an independent data and safety monitoring committee.
And Johnson & Johnson announced last month that its experimental vaccine for Covid-19 stimulated a strong immune response against the emerging corona virus in a clinical trial, from an early stage to a late stage, after which the company began conducting a final test involving 60,000 people, and its results were expected to be announced. Before the end of this year or early 2021.
The company declined to disclose the disease due to privacy concerns, saying that some study participants are receiving a placebo and it was not always clear whether a person suffering from something seriously harmful in a clinical trial had received a placebo or a treatment.
The US state news site, Health-Related, stated that the company took the suspension earlier in the day and cited a document sent to outside investigators, stating that “temporary suspension rules” were met. , closing the Internet system used to register patients in the study and requesting that a monitoring meeting be convened. Data and security.
