Johnson & Johnson pauses Covid vaccine trial as participant becomes ill

Johnson & Johnson has temporarily halted its Covid-19 vaccine trial because one of its participants became sick.

"We have temporarily paused further dosing in all our Covid-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant," the company said in a statement.

The pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.

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The participant's illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company's clinical and safety physicians, the company added.

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.

However, J&J's move follows a similar one by AstraZeneca Plc. In September, AstraZeneca paused late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, due to an unexplained illness in a UK study participant.

While trials in the UK, Brazil, South Africa and India have resumed, the US trial is still on hold pending a regulatory review.

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.

Johnson & Johnson declined to elaborate about the illness due to privacy concerns. 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.

(with inputs)