Coronavirus vaccine trial chaos as volunteer suffers ‘unexplained illness’

A Covid-19 vaccine trial with 60,000 patients has been paused after a patient suffered an unexplained illness.

The Johnson & Johnson study's online enrollment system has closed and an independent committee that oversees safety will be convened.

A document sent to outside researchers of the clinical trial states that a "passing rule" has been met, according to Stat News.

The data and safety monitoring board, an independent committee will convene following the news.

J&J confirmed the study pause and declined to provide further details to Stat.

“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.

They said that illnesses, accidents and other bad medical outcomes are expected as part of a clinical study.

They also stated there is a difference between a clinical hold and a study pause, with the former being a formal regulatory action that can last a lot longer.

The vaccine study is not under a clinical hold, with the company announcing holds to the public.

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It does not usually inform the public of study pauses. The data and safety monitoring board convened on 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.

Although study pauses can happen in clinical trials, there is a race to test vaccines against Covid-19 and the SARS-CoV-2 virus which causes coronavirus.

“If we do a study of 60,000 people, that is a small village,” a source familiar with the study said.

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"In a small village there are a lot of medical events that happen.”

On September 8, a large study of another coronavirus vaccine developed by AstraZeneca and Oxford University was put on hold, following a suspected adverse reaction in a patient in the UK.

It’s believed the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed approximately a week after the was paused in the United Kingdom, and have since been restarted in other countries as well.

It remains on hold in the United States. Johnson & Johnson began enrolling volunteers in its Phase 3 study on September 23.

Researchers planned to enroll 60,000 participants in the United States as well as other countries.

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