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

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 becomes the second to be paused in the U.S. after AstraZeneca’s vaccine trial was put on hold last month after a volunteer in Britain developed a neurological complication.

AstraZeneca’s trial has resumed in Britain, but is still paused in the United States as the U.S. Food and Drug Administration carries out an investigation.

Johnson & Johnson did not reveal the specifics of the unexplained illness but will be conducting a review to see if it is related to the vaccine. 

“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.

“Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”

When the trial’s move to Phase 3 was announced last month, the National Institutes of Health said it would involve up to 60,000 participants. 

The company’s vaccine is one of six being tested in the U.S. in the race to find an effective vaccine to ease the pandemic that has killed more than 215,000 Americans.

Johnson & Johnson’s vaccine requires only one dose of vaccine, so federal officials have expressed hope that testing can be carried out faster than studies of other vaccines which will require two doses, such as those made by Moderna and Pfizer, CNN reported. 

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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 vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

(Reporting by Ayanti

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 experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported here the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

Reporting

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 reasons.

Dr. Ashish Jha, dean of the Brown University School of Public Health, told CNN that the pause is “completely expected” due to how large the study is, and this is “just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3.” Jha added that it is important for the vaccine to be “safe and we’ve got to let the process play out and it’s going to take a while. To me, it’s reassuring that companies are acting responsibly and pausing when they need to.”

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Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

Budrul Chukrut | LightRocket | Getty Images

The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.

More from STAT News

Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.

“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.

J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.

The data and safety monitoring board, or DSMB, convened late 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.

Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.

Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said.

“If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.”

On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. 

Johnson and Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

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