“Adverse events – illnesses, accidents, etc. – even serious ones are an expected part of any clinical trial, especially large trials.”
Johnson & Johnson’s Janssen vaccine arm is developing the shot. The company didn’t say what the unexplained disease was, but one point of clinical trials is to find out if vaccines cause dangerous side effects. The tests are stopped when they appear as doctors check whether the disease may be related to the vaccine or is a coincidence.
“Based on our strong commitment to safety, all clinical trials conducted by Johnson & Johnson̵
“We must respect the privacy of this participant. We are also learning more about this participant’s illness and it is important to have all the facts before sharing more information,” the company added.
“Serious adverse events are not uncommon in clinical trials and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Furthermore, since many trials are placebo-controlled, it is not always immediately apparent. whether a participant received study treatment or a placebo. “
The manufacturer said there is a “significant distinction” between a study break and a regulatory suspension on a clinical trial.
“A study break, where recruitment or dosing is stopped by the study sponsor, is a standard component of a clinical trial protocol,” Johnson & Johnson said.
“A regulatory suspension of a clinical trial is a requirement by a health regulatory authority, such as the US Food and Drug Administration. As outlined in our transparency commitments, we proactively disclose any regulatory suspension of a key clinical trial.” .
This is the second phase 3 coronavirus vaccine trial to be suspended in the United States. AstraZeneca’s vaccine trial was suspended last month due to a neurological complication in a volunteer in Britain. While the trial is resumed there and in other countries, it remains on hiatus in the United States while the U.S. Food and Drug Administration investigates.
Johnson’s Phase 3 trial began in September. It is one of six coronavirus vaccines tested in the United States and one of four in the most advanced stage 3. It only requires one dose of the vaccine, so federal officials said they hope the tests can compete a little faster than other vaccines, including those made by Moderna and Pfizer, which require two doses.