Johnson & Johnson Suspends COVID-19 Vaccine Trials After Unexplained Illness In Participant, Company Says


Johnson & Johnson, one of several companies vying to create a vaccine for COVID-19, has suspended vaccine trials after an “unexplained illness” in one of the participants, the company said Monday evening.

The company, which is headquartered in New Brunswick, said the participant’s illness was being reviewed by ENSEMBLE’s independent data security oversight committee, as well as internal physicians at the clinic and safe.

“Adverse events – illnesses, accidents, etc. – even severe ones are an expected part of any clinical study, especially large studies, ”Johnson & Johnson said in a statement. “Based on our strong commitment to safety, all clinical studies conducted by the Janssen pharmaceutical companies of Johnson & Johnson have predefined guidelines.

“This ensures that our studies can be put on hold if an unexpected serious adverse event that could be related to a vaccine or study drug is reported, so that there can be careful consideration of all medical information before to decide to restart the study. “

Johnson & Johnson said they were working to learn more about the participant’s illness and said they would not share any more information at this time.

He added that “serious adverse events” like this are not uncommon in clinical trials either.

“SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants,” the company said. “Additionally, since many trials are placebo-controlled, it is not always immediately obvious whether a participant received study treatment or a placebo.”

Johnson & Johnson was in the midst of a large final study to try to prove whether a single dose COVID-19 vaccine can protect against the virus.

The third phase began in mid-September and is one of the largest coronavirus vaccine studies in the world to date and includes 60,000 volunteers in the United States, South Africa, Argentina, Brazil, in Chile, Colombia, Mexico and Peru.

A handful of other vaccines in the United States – including injections made by Moderna Inc. and Pfizer Inc. – and others in other countries are already in the final stages of testing. The hope is high that answers on at least one candidate tested in the United States could arrive by the end of the year, possibly sooner.

This article contains material from The Associated Press.

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Chris Sheldon can be reached at [email protected].


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