Tag: Unexplained

Johnson & Johnson Paused Trials on Its COVID-19 Vaccine Due to Subject’s “Unexplained Illness”

October 14, 2020
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Update, Oct. 13: Johnson & Johnson announced that it has paused all of its COVID-19 vaccine candidate clinical trials, including a large-scale Phase 3 human trial called “Ensemble” that began in September and aimed to enroll up to 60,000 people across three continents. One of the participants in that trial had an “unexplained illness,” the company said.

The Phase 3 clinical trial was in the process of comparing the efficacy of a single-dose vaccine versus a placebo. A company statement explained that the participant’s illness is currently being reviewed, and no other information has been released about the participant’s condition out of privacy. “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” the company wrote. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

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Johnson & Johnson Pauses Coronavirus Vaccine Trials due to ‘Unexplained Illness’ in Participant | Health News

October 13, 2020
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Johnson & Johson has paused the clinical trial for its coronavirus vaccine following an “unexpected illness” in a participant.

Health experts have said that pauses in vaccine trials aren’t uncommon and mean that safety precautions are working. It’s the second vaccine trial to be paused in the U.S. A vaccine from AstraZeneca and Oxford University was put on pause last month after a participant fell ill. That trial hasn’t yet resumed in the U.S.

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It is unclear how long Johnson & Johnson’s pause could last. The company said there is a “significant distinction” between a study pause and a regulatory hold of a clinical trial, which could last much longer.

“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 press release Monday night.

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

October 13, 2020
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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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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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J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

October 13, 2020
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(Reuters) – Johnson & Johnson

has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca

also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus

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J&J pauses coronavirus vaccine trials due to unexplained illness

October 13, 2020
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(Reuters) – Johnson & Johnson JNJ.N has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca AZN.L also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its

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Johnson & Johnson COVID-19 vaccine trial paused due to ‘unexplained illness’

October 13, 2020
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Johnson & Johnson on Monday night announced that it has paused its COVID-19 vaccine trial due to one of the volunteers coming down with an “unexplained illness.”

In a statement, Johnson & Johnson said that under its guidelines, the “participant’s illness is being reviewed and evaluated” by the study’s independent Data Safety Monitoring Board (DSMB), as well as internal clinical and safety physicians. The company also said that “adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

Johnson & Johnson’s vaccine arm, Janssen, began the Phase 3 clinical trial in September. There are 60,000 participants, and each are receiving one dose of the vaccine. Advanced clinical trials are conducted so researchers can determine whether participants are experiencing side effects, and Johnson & Johnson said it is not revealing what illness the volunteer has due to privacy

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Johnson & Johnson pauses COVID-19 vaccine trial due to unexplained illness

October 13, 2020
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The drug and pharmaceutical company failed to provide additional information about the trial participant’s illness.

Johnson & Johnson has halted its advanced clinical trials for a coronavirus vaccine due to an “unexplained illness” of a volunteer participating in medical tests, CNN reports.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the drug and pharmaceutical company said in a statement of the study, which is named ENSEMBLE.

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

It’s not clear what the unexplained illness is, however, as CNN points out, such clinical trials could cause side effects for participants. Trials are commonly stopped when side effects occur. Doctors are then able to evaluate the illness and

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J&J pauses COVID-19 vaccine trials due to unexplained illness in participant

October 13, 2020
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(Reuters) – Johnson & Johnson JNJ.N said on Monday it had temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

FILE PHOTO: The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid

The participant’s illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company’s clinical and safety physicians, the company said here in a statement.

J&J, which reports quarterly financial results on Tuesday morning, said that such pauses are normal in big trials, which can include tens of thousands of people. It said the “study pause” in giving doses of the vaccine candidate was different from a

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2nd COVID-19 Vaccine Trial Paused Over Unexplained Illness | Business News

October 13, 2020
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NEW BRUNSWICK, N.J. (AP) — A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot.

The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.

The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S.

The company declined to reveal any more details about the illness, citing the participant’s privacy.

Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of

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