Reuters News Service 13 October 2020
(Reuters) - 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 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 said in a statement.
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.
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 U.S. trial is still on hold pending a regulatory review.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email that "Everybody is on the alert because of what happened with AstraZeneca," adding that it could take a week to gather information.
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