Tag: Participants

Community ties are key to diversifying participants | Articles

October 13, 2020
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| Community Health

“Researchers think this is a really good thing to have as many diverse patients as possible,” he said. “Hopefully that will continue. That’s where I’m super excited about it.”

For COVID-19, in particular, people who are interested in participating in trials will have plenty of other opportunities, he said. Meridian expects to offer trials for several other vaccines before the end of the year.

The company also is recruiting younger people, down to age 16 for now, for the trials. And dozens more vaccine candidates are in the development pipeline, according to the New York Times vaccine tracker.

The workforce at many meatpacking plants is strikingly diverse — workers may be white, Latino, East African or Southeast Asian, among other groups.

Eric Reeder, president of United Food & Commercial Workers Local 293, sent text messages to an estimated 7,000 workers and put up fliers in several plants and the union

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Johnson & Johnson pauses Covid vaccine trial over participant’s ‘unexplained illness’

October 13, 2020
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| Health News

Johnson & Johnson has paused its Covid-19 vaccine trial due to an “unexplained illness” in a participant, the company confirmed.



a close up of a device: Photograph: Siphiwe Sibeko/Reuters

© Provided by The Guardian
Photograph: Siphiwe Sibeko/Reuters

The pharmaceutical giant was unclear if the patient was administered a placebo or the experimental vaccine, and it’s not remarkable for studies as large as the one Johnson & Johnson are conducting – involving 60,000 patients – to be temporarily paused.

Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

Nevertheless, with several drug companies racing to develop a coronavirus vaccine, facilitated by Operation Warp Speed, the US government effort to speed up development the news of any setbacks are being closely watched by politicians and Americans eager for a way out of a pandemic that has killed more than 214,000.



a close up of a device: It is not unusual for large studies like Johnson & Johnson’s to pause.

© Photograph: Siphiwe Sibeko/Reuters
It is not unusual for large studies like Johnson & Johnson’s to pause.

Video: Coronavirus

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Johnson & Johnson Pauses COVID-19 Vaccine Clinical Trials over Participant’s ‘Unexplained Illness’

October 13, 2020
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| Health

Johnson & Johnson has paused its late stage clinical trials for a COVID-19 vaccine because of an “unexplained” illness in one of the participants, the company said Monday. 

It said in a news release that the trial was paused while the study’s independent Data Safety Monitoring Board conducted a review and evaluation of the participant’s condition.

“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

The company noted the “significant distinction” between a study pause and a regulatory hold, explaining that a pause is not unexpected in vaccine trials. 

“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the statement said.

Johnson & Johnson’s coronavirus vaccine became the fourth to begin Phase 3 trials in the United States last month and

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