Johnson & Johnson pauses COVID-19 vaccine trial due to unexplained illness
The drug and pharmaceutical company failed to provide additional information about the trial participant's illness.
Johnson & Johnson has halted its advanced clinical trials for a coronavirus vaccine due to an “unexplained illness” of a volunteer participating in medical tests, CNN reports.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the drug and pharmaceutical company said in a statement of the study, which is named ENSEMBLE.
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
It’s not clear what the unexplained illness is, however, as CNN points out, such clinical trials could cause side effects for participants. Trials are commonly stopped when side effects occur. Doctors are then able to evaluate the illness and determine whether or not it’s tied to the vaccine.
“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” Johnson & Johnson said in their statement.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional 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. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”
What’s more, Johnson & Johnson emphasized that pauses in studies commonly occur.
“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the company said.
“A regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration. As outlined in our transparency commitments, we proactively disclose any regulatory hold of a pivotal clinical trial.”
This makes the second Phase 3 COVID-19 vaccine trial to be paused in the United States. Currently, there are six coronavirus vaccines being tested in the country and only four in the advanced stage known as Phase 3.
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