Johnson & Johnson pauses COVID-19 vaccine trial over 'unexplained illness'
NEW YORK - Drug-maker Johnson & Johnson says it is temporarily pausing clinical trials of a COVID-19 vaccine due to "an unexplained illness in a study participant."
The New Jersey-based company says the participant’s illness is being reviewed and evaluated by an independent board.
In a statement, the company said, "At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles."
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J&J says adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies, and said pauses are not uncommon in clinical trials.
The company did not release information on the illness or the participant to protect their privacy.
"It’s important to have all the facts before we share additional information," the company stated.
A study pause is not as serious as a regulatory hold.