Johnson & Johnson said on Monday that it had temporarily suspended clinical trials of the Covid-19 vaccine after a volunteer in the study became ill with an unexplained disease, 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 the company’s doctors and safety doctors.
Johnson & Johnson, which announces on Tuesday morning the quarterly financial results, added that such a temporary suspension is normal in the case of major trials, which could include tens of thousands of people, and said that “suspending the study”, in terms of administering the expected vaccine doses, It differs from the “regulatory suspension” required by health authorities.
Johnson & Johnson’s move comes after a similar procedure taken by the “AstraZeneca” company last September, which had previously suspended trials of late stages of its experimental vaccine for Coronavirus, which was developed in cooperation with the University of Oxford, due to an inexplicable disease of a volunteer in the British study.
Although trials have resumed in Britain, Brazil, South Africa and India, US trials are still pending due to regulatory review.
“Everyone is alert because of what happened with AstraZeneca,” William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine, said by e-mail, adding that it could take a week to collect the information.
He said, “It must be a serious harmful thing. If it is something like prostate cancer or uncontrolled diabetes or a heart attack, they will not stop the study for any of these reasons, it is likely that this thing is related to the nerves.”
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 that the company began conducting a final trial that includes 60,000 people, and its results were expected to be announced. Before the end of this year or early 2021.
The company refused to disclose the disease due to privacy concerns, and said that some study participants are getting a placebo, and it was not always clear if a person suffering from something seriously harmful in a clinical trial had received a placebo or a treatment.
The US state news site, concerned with health affairs, stated that the suspension was taken by the company earlier in the day and cited a document sent to external researchers, stating that the “temporary suspension rules” were fulfilled, shutting down the internet system used to register patients in the study, and calling for a monitoring board to convene Data and safety.