J&J COVID-19 vaccine trials paused due to unexplained illness in candidate
JNJ.N, Johnson & Johnson said on Monday it had temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.
The company said in a statement that the participant’s illness is under review and evaluated by an independent data and safety monitoring board as well as the company’s clinical and safety physicians.
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J&J, which reports quarterly financial results on Tuesday morning, said that such pauses are normal in big trials, which can include tens of thousands of people. It said the “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” required by health authorities. The current case is a pause.
“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 said.
Last month, J&J said its experimental COVID-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, following which the company kicked off a final 60,000-person trial, whose results had been expected by the end of this year or early 2021.
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Due to privacy concerns, Johnson & Johnson declined to elaborate about the illness. It did say that some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a clinical trial received a placebo or the treatment.
-PTC News
