Johnson & Johnson pauses its COVID-19 vaccine study after ‘unexplained illness’ in one of its 60,000 volunteers
- Johnson&Johnson announced tonight it was pausing its study
- A document sent to researchers running the 60,000-patient clinical trial said a ‘pausing rule’ had been met
- This is the third COVID-19 vaccine trial to be paused
Johnson & Johnson’s COVID-19 vaccine study has been paused due to an unexplained illness in a study participant.
A document obtained by Stat News which was sent to outside researchers running the 60,000-patient clinical trial states that a ‘pausing rule’ has been met.
It also stated that the online system used to enroll patients in the study has been closed and the data and safety monitoring board would be convened.
Johnson & Johnson confirmed the news to Stat News, saying it was due to ‘an unexplained illness in a study participant.’
The company declined to provide further details and cited patient privacy.
In this undated photo provided by Johnson&Johnson, a woman receives an injection during phase 3 testing of a COVID-19 vaccine. The company announced on Monday it was pausing the trial after a patient experienced an ‘unexplained illness’
‘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 said in a statement.
‘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 added.
‘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.’
This is the second vaccine study to be paused. On September 8, a large study run by AstraZeneca and Oxford University was put on hold because a patient in the United Kingdom experience a suspected adverse reaction.
It’s believed the patient developed a spinal cord problem. Studies in the UK resumed about a week later, but it is still on hold in the United States.
Johnson & Johnson started enrolling patients in its phase 3 study on September 23. Researchers planned to enroll 60,000 participants in the U.S. and other countries.
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