- Johnson & Johnson on Monday said that it had paused its late-stage coronavirus vaccine trial after a participant had an unexplained illness.
- The pause, first reported by Stat News, came just weeks after the pharma giant launched the massive study to evaluate whether the shot can prevent COVID-19.
- In a statement Monday, J&J provided little additional information. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
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Johnson & Johnson said Monday that it had temporarily halted its coronavirus vaccine trials after a participant experienced an unexplained illness, the second major setback to hit a late-stage test of a coronavirus immunization.
The pharma giant said it paused all further dosing in the trials after a participant fell ill. The pause in the trial, which is aiming to enroll 60,000 people to determine if the vaccine is safe and effective, was first reported by Stat News’ Matthew Herper.
J&J said the participant’s illness is being reviewed by an independent board as well as by company doctors. The company didn’t share more information about the nature of the illness, citing patient privacy.
“We must respect this participant’s privacy,” J&J said in a statement. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
A coronavirus vaccine trial from British drugmaker AstraZeneca is facing a similar setback. In September, AstraZeneca paused the trial after a participant had a potential adverse reaction. The UK arm of the trial has resumed, though the US portion of the trial is still paused and being investigated further by the US Food and Drug Administration.
Other late-stage vaccine trials from Pfizer and Moderna are underway, and they could yield results this year.
J&J, the world’s largest healthcare company, started its late-stage trial in September to determine whether the shot can prevent COVID-19. The trial is also designed to provide information about whether the vaccine is safe to administer to potentially millions of people.
The trial had initially expected to yield early results by the end of 2020. Depending on how long the trial is paused, the findings could be delayed. J&J didn’t provide any information about the length of the pause.
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