A Blog by Jonathan Low

 

Oct 13, 2020

Johnson and Johnson Has To Pause Covid Vax Trial Due To Unexplained Illness

Several other Covid vaccine trials have also been paused. Whether this is endemic to the nature of a Covid vaccine or a more worrisome sign problems is not yet clear. 

The good news is that the issues and pauses are being reported. That so little information about the issues is being provided is not a good sign for the eventual transparency needed to get massive numbers of people to take a Covid vaccine. JL

Matthew Herper reports in Stat:

The study pause was due to “an unexplained illness in a study participant.” A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened.Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur,

The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.

Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.

“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 said in a statement.

 

 

The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.

Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.

Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said.

“If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.”

On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. 

Johnson & Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

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