Johnson & Johnson has paused its coronavirus vaccine research study following an adverse reaction by one of the participants.
“At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world,” the company said in a statement.
Vaccine Research Paused
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“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials,” the company also stated. This includes “the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” it added. “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 company stated that we must respect this participant’s privacy. They are “also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
The statement also explains that adverse events are an expected part of any clinical stud. It added that 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,” the company said. “So there can be a careful review of all of the medical information before deciding whether to restart the study.”