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- “Adverse events - illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies,” the statement said.
- Clinical trials are often resumed quickly after the illness is found not to be a serious health risk.
- This is the second coronavirus vaccine trial to be paused in the U.S.
Pharmaceutical giant Johnson & Johnson has temporarily paused its clinical trials for a COVID-19 vaccine candidate after a participant fell ill.
The company halted the large late-stage clinical trial of a possible coronavirus vaccine due to an “unexplained illness” in one of the volunteers. It’s unclear what the illness was and whether the participant received the experimental vaccine or was given the placebo.
“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,” Johnson & Johnson said in a statement Monday announcing the pause.
“Adverse events - illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies,” the statement said.
Clinical trials are often resumed quickly after the illness is found not to be a serious health risk.
The experimental vaccine developed by the company’s subsidiary, Janssen Pharmaceutical Companies, went into phase three trials last month with 60,000 participants.
It’s the fourth vaccine in the U.S. to enter late-stage trials, trailing candidates developed by Pfizer/BioNTech, Moderna and AstraZeneca.
Unlike the other vaccine candidates, Johnson & Johnson’s will require just one dose instead of two if it is proven to be safe and effective.
This is the second coronavirus vaccine trial to be paused in the U.S.
Two participants in AstraZeneca’s coronavirus vaccine trial became seriously ill after receiving the vaccine, prompting the trial to be paused twice. The trial was most recently paused last month and has yet to continue in the U.S.
Health officials have projected that a safe and effective coronavirus vaccine could be made available to high risk groups before the year is out. A vaccine isn’t likely to be broadly available to all Americans until several months into 2021.
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