Johnson & Johnson paused its late-stage clinical trial for a potential COVID-19 vaccine, dubbed ENSEMBLE, on Monday due to an unexplained illness in a study volunteer.
“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 maker said in a statement.
“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies.”
The company did not specify the illness involved, and it is unclear whether the patient received the experimental vaccine or was in the placebo-control group, NBC News reported.
“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 stated.
According to CNN, clinical trials are frequently halted as ailments in participants arise in order to determine if the afflictions are side effects of the vaccines being tested or purely coincidental.
AstraZeneca also started its Phase 3 vaccine trial last month but was paused in the United Stated after a participant in the United Kingdom was reported to have developed a spinal cord injury. The company has since resumed its study in the United Kingdom but is still awaiting U.S Food and Drug Administration approval to proceed in the United States, NBC News reported.
“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 stated.
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