“Adverse events – illness, accidents, etc. – are serious, they are an expected part of any clinical study, especially large studies.”
Johnson and Johnson’s Jansson are developing vaccine hand shots. The company did not say what the disease explained, but one point of clinical trials is to find out if the vaccines cause dangerous side effects. Trials stop when a pop-up occurs when doctors check that the disease may be linked to a vaccine or that it is a coincidence.
“Based on our strong commitment to safety, all clinical studies conducted by Johnson & Johnson’s pharmaceutical companies are predefined guidelines. This ensures that if any unforeseen adverse event (SAE) may be related to the vaccine or the study may be reported. Comes, so all medical information can be carefully reviewed before deciding whether to resume the study, ”the company said.
The company added, “We must respect the privacy of this participant. We are also learning more about this participant’s illness, and must have all the facts before sharing additional information,” the company added.
“Severe adverse events are not uncommon in clinical trials, and tests involving a large number of participants can be expected to reasonably increase the likelihood of serious adverse events. Got a placebo. “
The drug manufacturer said there was a “significant difference” between the study pause and the regulatory hold relating to the clinical trial.
“Pause a study, in which the recruitment or dosage is paused by the study sponsor, is a standard component of the clinical trial protocol,” Johnson and Johnson said.
“The regulatory hold of a clinical trial is required by a regulatory health authority such as the U.S. Food and Drug Administration. As outlined in our transparency commitments, we will actively disclose any regulatory hold of a minor clinical trial.”
U.S. This is a second phase 3 coronavirus vaccine trial stopped in. The trial of the AstraZeneca vaccine was postponed last month due to neurological complications in volunteers in Britain. When the trial resumed there and in other countries, U.S. While investigating the Food and Drug Administration, it has stalled in the United States.
Johnson’s Phase 3 trial began in September. That U.S. Is one of the six coronaviruses being tested in, and one of the four stages of the coronavirus. It requires only one dose of the vaccine, so federal officials have said they hope the test will be fought a little faster than other vaccines, including those made by Moderna and Pfizer.
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