Johnson & Johnson Claims that Adverse Reaction is ‘Expected’ to Happen
After having an unexplained adverse health reaction suffered by one of the trial participants, Johnson & Johnson stopped its trial of an experimental COVID-19 vaccine.
The drugmaker didn’t disclose the unexplained illnesses for the patient’s privacy. However, Johnson’s & Johnson’s stated that it follows the guidelines which require trials to be paused if a serious reaction happens that could potentially be connected to the vaccine.
As of this time, the patient’s illness is “being reviewed and evaluated.”
“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” Johnson & Johnson added.
“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,” the company added.
Stopping the Vaccine Trial
According to Johnson & Johnson, it’s discovering more about the adverse reaction and that it’s “important to have all the facts before we share additional information.”
“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.”
Johnson & Johnson asserted that a “study pause” doesn’t equate to the actual end of the testing process.
“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” Johnson & Johnson stated.
Editor’s note on “Johnson & Johnson Stops Vaccine Trial After Adverse Reaction”:
This piece is to inform you about the pause of the Johnson & Johnson Vaccine Trial.
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