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on October 14, 2020October 14, 2020health

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

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.”

This pause, Johnson & Johnson explained, is different than a regulatory hold put in place by a health authority such as the FDA. “As noted in the ENSEMBLE study protocol, Johnson & Johnson has robust mechanisms in place to protect the safety of participants in its clinical trials. While the Company informs all study investigators, we typically do not communicate study pauses publicly,” the company’s statement reads (it does, however, normally disclose information about regulatory holds). Stat News was the first outlet to report on this trial pause on Oct. 12.

Original post: Pharmaceutical brand Johnson & Johnson has been working on a coronavirus vaccine since January 2020, as soon as the virus’s genetic sequence became available. On March 30, the company announced plans to begin human testing of the vaccine in September, working towards an anticipated emergency use date in early 2021.

It’s a “substantially accelerated timeline,” the company noted in a press release; typical vaccine development can take five to seven years before a viable candidate is considered for approval, it said. The company’s manufacturing sector is ramping up production as well, with the goal of eventually providing over one billion doses of the vaccine globally.

“The world is facing an urgent public health crisis,” said Alex Gorsky, the chairman and CEO of Johnson & Johnson, in the press release. “We are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible.” He noted that the company’s research, operational, and financial capabilities put it in a favorable position to quickly develop and distribute a vaccine.

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Johnson & Johnson has also partnered with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to commit $1 billion in funding towards vaccine research, development, and testing, the company said.

It’s hopeful news, especially considering that Johnson & Johnson is just one of multiple pharmaceutical companies rapidly working towards a COVID-19 vaccine; Moderna’s vaccine began its

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on October 13, 2020October 13, 2020health

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.
(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 ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company added.

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

The temporary halt is not the first to occur in the race to find a safe and effective vaccine to protect against COVID-19. In fact, the pause is the second such hold to occur among several vaccine candidates that have reached large-scale final tests in the U.S.

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Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

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The Associated Press contributed to this report.

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on October 13, 2020October 13, 2020health

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.

The vaccine’s phase three trial launched last month, making it the fourth vaccine candidate to reach final stage trials in the U.S. The company at the time said it plans to enroll up to 60,000 volunteers at more than 200 clinical research sites in the U.S. and other countries. The vaccine was developed by Belgium-based Janssen Pharmaceutical Companies, which is a subsidiary of Johnson & Johnson.

The vaccine requires just one dose, making it logistically easier to produce and roll out than one that requires two doses with time in between each injection.

Source Article …

on October 13, 2020October 13, 2020health

Johnson & Johnson COVID-19 vaccine trial paused by unexplained illness

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.

USA TODAY

Johnson & Johnson’s COVID-19 vaccine trial has been paused due to an unexplained illness in a volunteer. Now two of the four vaccine trials in the United States are now on hold.

The Phase 3 clinical trial was temporarily halted Monday, according to the company. It is not known if the unidentified illness is related to the vaccine, but clinical protocols require a pause while it is investigated.

Johnson & Johnson’s JNJ-78436735 vaccine is one of four large-scale, final-stage COVID-19 vaccine trials underway in the U.S. Another trial, run by AstraZeneca, was halted Sept. 8 after a second participant was diagnosed with a neurological condition.

Johnson & Johnson said Monday it has paused further dosing in its trial while the participant’s illness is reviewed and evaluated by an independent Data Safety Monitoring Board as well as the company’s clinical and safety physicians.

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In any study the size of the Johnson & Johnson one, which will include up to 60,000 people when it is fully enrolled, some adverse events are expected among the participants. Such studies have clear, prespecified guidelines that say what events would trigger a shutdown.

The independent Data Safety Monitoring Board, which oversees the trial, will review what happened and decide whether it is safe to resume the trial.

Labs are studying potential COVID-19 vaccines. (Photo: Chandan Khanna/ AFP via Getty Images)

Johnson & Johnson did not say what the illness was nor where the participant lived.

Participants began enrolling in the trial on Sept. 23.

The vaccine was developed by Janssen Research & Development, a subsidiary of Johnson & Johnson. It is delivered by a harmless virus called Adenovirus 26, a human virus uncommon in nature so most people have not developed immunity to it.

The 30,000-person AstraZeneca trial has been on hold since Sept. 8, about a week after launching.

A participant in a similar AstraZeneca trial in the United Kingdom developed a serious neurological condition that might have been caused by the vaccine, so AstraZeneca halted all its COVID-19 vaccine trials around the world while the case could be investigated.

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AstraZeneca also stopped its trials briefly in July because another participant developed symptoms of the neurological condition multiple sclerosis, although news of that stoppage was not made public until the second case. The first person was determined “to have an undiagnosed case of multiple sclerosis, which the independent panel concluded was unrelated to the vaccine,” the company said.

The AstraZeneca vaccine, based on technology

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on October 13, 2020October 13, 2020health

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

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on October 13, 2020October 13, 2020health

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.