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The US pharmaceutical company Johnson & Johnson said it had suspended its clinical trials on its experimental emerging coronavirus vaccine (Covid-19) after one of the trial participants showed symptoms of an unexplained illness.
The group announced in a statement that the decision to stop the trials is a temporary decision and includes all additional vaccines in all clinical trials, according to the US site “usatoday.”
He noted that it is not known if the unknown disease is related to the vaccine, but that clinical protocols require a pause while they are investigated.
The Johnson & Johnson protocols state that if a serious adverse event occurs during a study, the study is suspended to indicate whether the event is related to the drug being evaluated and to determine if the study can be resumed.
The company said in its statement: “We have temporarily halted all additional vaccines in all of our clinical trials for an experimental Covid-19 vaccine, including the full Phase III trial, due to an unexplained illness that one of the participants in the study.
The group explained that “the occurrence of dangerous undesirable events is to be expected in any clinical study, especially in large studies.”
The US company confirmed that “in accordance with the decision to suspend clinical trials, an online registration system (created in September to collect 60,000 volunteers) was closed to participate in the third and final phase of clinical trials, and also invited the Independent Committee on Patient Safety to convene to investigate this development. “
The Johnson & Johnson vaccine is one of four large-scale end-stage Covid-19 vaccine trials underway in the United States, and another trial, led by AstraZeneca, was halted on September 8 after another participant will be diagnosed with a neurological condition.
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