Tag: unexplained

By iwano@_84

Johnson & Johnson pauses coronavirus vaccine trial following ‘unexplained illness’ in participant

Pharmaceutical giant Johnson & Johnson on Monday night announced that it had paused its late-stage COVID-19 vaccine trial after an “unexplained illness” was reported in a participant. 

“Adverse events – illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement when announcing the temporary halt. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 
(iStock)

No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence. It’s also not clear if the volunteer had received the vaccine or the placebo. 

“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These

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By iwano@_84

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

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.

Photos: Daily Life, Disrupted

TOPSHOT - A passenger in an outfit (R) poses for a picture as a security guard wearing a facemask as a preventive measure against the Covid-19 coronavirus stands nearby on a last century-style boat, featuring a theatrical drama set between the 1920s and 1930s in Wuhan, in Chinas central Hubei province on September 27, 2020. (Photo by Hector RETAMAL / AFP) (Photo by HECTOR RETAMAL/AFP via Getty Images)

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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By iwano@_84

J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

(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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By iwano@_84

J&J pauses coronavirus vaccine trials due to unexplained illness

(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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By iwano@_84

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

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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By iwano@_84

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

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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