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Johnson & Johnson pauses Covid vaccine trial as participant turns into ailing – Home Health Choices

WASHINGTON: Johnson & Johnson mentioned on Monday it had briefly paused its Covid-19 vaccine candidate scientific trials as a result of an unexplained sickness in a examine participant, delaying one of many highest profile efforts to include the worldwide pandemic.

The participant’s sickness is being reviewed and evaluated by an impartial knowledge and security monitoring board in addition to the corporate’s scientific and security physicians, the corporate mentioned in a press release.

J&J, which experiences quarterly monetary outcomes on Tuesday morning, mentioned that such pauses are regular in massive trials, which might embody tens of hundreds of individuals. It mentioned the “study pause” in giving doses of the vaccine candidate was completely different from a “regulatory hold” required by well being authorities. The present case is a pause.

However, J&J’s transfer follows the same one by AstraZeneca. In September, AstraZeneca paused late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, as a result of an unexplained sickness in a UK examine participant.

While trials within the UK, Brazil, South Africa and India have resumed, the US trial continues to be on maintain pending a regulatory overview.

Dr William Schaffner, a professor of infectious illnesses on the Vanderbilt University School of Medicine, mentioned by e-mail that “Everybody is on the alert because of what happened with AstraZeneca,” including that it may take every week to collect info.

“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 any of those reasons. This is likely to be a neurological event,” he mentioned.

Last month, J&J mentioned its experimental Covid-19 vaccine produced a powerful immune response towards the novel coronavirus in an early-to-mid stage scientific trial, following which the corporate kicked off a remaining 60,000-person trial, whose outcomes had been anticipated by the top of this yr or early 2021.

Johnson & Johnson declined to elaborate concerning the sickness as a result of privateness issues. It did say that some members in research get placebos, and it was not at all times clear whether or not an individual struggling a severe antagonistic occasion in a scientific trial obtained a placebo or the therapy.

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