WASHINGTON | Pharmaceutical group Johnson & Johnson announced on Monday the suspension of its clinical trial of a vaccine against COVID-19, one of the participants having fallen ill.
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“We have temporarily halted additional dosing in all of our clinical trials of an investigational COVID-19 vaccine, including the entire Phase 3 trial, due to unexplained illness in one participant,” said the group said in a statement.
This suspension leads to the closure of the online registration system set up at the end of September to recruit 60,000 participants in the context of phase 3 of the trial, while the independent committee for patient safety was seized.
Serious adverse events are “an expected component of any clinical study, especially large studies,” Johnson & Johnson said. The protocols in force in the company provide for the suspension of a study to determine if the serious adverse event is related to the drug being evaluated and if it is possible to resume the trial.