J&J pauses COVID-19 vaccine trials due to unexplained illness in participant
(Reuters) - Johnson & Johnson <JNJ.N> announced Monday that clinical trials of COVID-19 vaccine candidates were temporarily suspended due to an unexplained illness in a study participant, delaying one of the most well-known efforts to contain the global pandemic.
The participant's illness will be reviewed and assessed by an independent data and safety monitoring body and the company's clinical and safety physicians. The company announced this: https://www.jnj.com/our-company/johnson-johnson-temporary-pausen -all-dosage-in-our-janssen-covid-19-vaccine-candidate-clinical-trials in an explanation.
J&J, which publishes quarterly financial results Tuesday morning, said such breaks are normal in large studies that tens of thousands of people can participate in. It was said that the "study break" in the administration of the vaccine candidate was different from the "regulatory waiver" demanded by the health authorities. The current case is a pause.
However, J & J's move follows a similar move by AstraZeneca Plc. In September, AstraZeneca <AZN.L> paused late-stage studies of its experimental coronavirus vaccine, which was being developed at Oxford University, due to an unexplained disease in a UK study participant.
While trials have resumed in the UK, Brazil, South Africa and India, the US trial is pending regulatory review.
Dr. William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine, said via email, "Everyone is on the alert as to what happened to AstraZeneca." It could take a week to collect information.
"It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes, or a heart attack, they wouldn't stop it for either of those reasons. This is likely a neurological event," he said.
Last month, J&J announced that its experimental COVID-19 vaccine had produced a strong immune response against the novel coronavirus in an early to mid-range clinical trial. The company then started a final study involving 60,000 people, the results of which were expected by the end of this year or early 2021.
Johnson & Johnson declined to elaborate on the disease for privacy reasons. It has been said that some study participants were given placebos, and it was not always clear whether a person suffering from a serious adverse event in a clinical trial was given a placebo or treatment.
Stat News reported on https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium = social & utm_source = twitter & utm_campaign = twitter_organic closed the break earlier in the day, citing a document sent to outside researchers stating that a "break rule" was followed, the online system for enrolling patients in the study was closed and the data and security monitoring was closed Board would convene.
(Reporting by Ayanti Bera in Bengaluru, Deena Beasley in Los Angeles and Peter Henderson in Oakland; editing by Rashmi Aich)
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