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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.

Related: If You Have COVID-19 Symptoms, This Is How You Can Take Care of Yourself at Home

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

Johnson & Johnson moves to buoy investors over paused Covid vaccine trial

US pharmaceutical giant Johnson & Johnson sought Tuesday to reassure investors after its stock slumped on an announcement that it was pausing a Covid-19 vaccine trial over a sick participant.

The company is one of several working on a vaccine, but on Monday it announced the unexplained illness, closing enrollment for the 60,000-patient trial while an independent patient safety committee is convened.

The announcement sent shares tumbling 2.3 percent at the close of trading Tuesday, even as the company reported healthy third-quarter results, with sales growing 1.7 percent to $21.08 billion.

In a conference call earlier in the day, J&J’s global research head Mathai Mammen said “our plan is to continue the study” following “a temporary pause” caused by the illness.

“It’s not at all unusual for unexpected illnesses (to occur) in large studies over their duration. In some cases, serious adverse events… may have something or nothing to do with the drug or vaccine being investigated,” he said.

The Phase 3 trial had started recruiting participants in late September, with a goal of enrolling volunteers across more than 200 US and international locations, the company and the US National Institutes for Health (NIH), which is providing funding, said.

The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

The company’s chief financial officer Joe Wolk said it was unclear whether the participant who became ill was receiving the trial vaccine or the placebo.

“We are waiting for the independent drug safety monitoring board to do their analysis,” he said.

J&J is one of 11 organizations globally to begin a Phase 3 trial on a Covid-19 vaccine.

Washington has given the multinational about $1.45 billion in funding under Operation Warp Speed.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

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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 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. 

CLOTH CORONAVIRUS FACE MASKS WORK — BUT ONLY IF YOU DO THIS AFTER WEARING THEM, STUDY FINDS

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.

RISKIEST BEHAVIORS TO AVOID DURING CORONAVIRUS PANDEMIC, ACCORDING TO AN EXPERT

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.

CLICK FOR COMPLETE CORONAVIRUS COVERAGE 

The Associated Press contributed to this report. 

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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.

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Johnson & Johnson vaccine trial; WHO herd immunity

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Since the coronavirus pandemic started, the United States has recorded more than 7.6 million cases of COVID-19 and 213,000 deaths.

USA TODAY

A third of U.S. states are reporting higher coronavirus case counts than they’ve ever had before.

A USA TODAY analysis of Johns Hopkins data shows 16 states set records for new cases in a week. But nearly all the states are surging: 41 states had worse weeks than they did a week earlier. And an analysis of COVID Tracking Project data shows that in 36 states, a higher rate of people were testing positive than in the week before.

While the data continue to show the virus’ reach is not letting up, the head of the World Health Organization said achieving herd immunity by allowing the virus to spread is “scientifically and ethically problematic.”

“Herd immunity is achieved by protecting people from a virus, not by exposing them to it,” WHO Director-General Tedros Ghebreyesus said Monday, adding that the strategy relies on vaccination.

The quest for a vaccine, however, ran into trouble on Monday when Johnson & Johnson paused its Phase 3 clinical trial because of a participant’s unexplained illness. It’s the second of four large-scale, final-stage vaccine trials to go on hold as Trump pushes for a vaccine by Election Day on Nov. 3.

Some significant developments:

📈 Today’s numbers: The U.S. has reported more than 7.8 million cases and 215,000 deaths, according to Johns Hopkins data. There have been more than 37.8 million confirmed cases around the world and 1 million deaths.

🗺️ Mapping coronavirus: Track the U.S. outbreak, state by state.

This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.

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Here’s where cases are surging in the US

A USA TODAY analysis of Johns Hopkins data shows 16 states set records for new cases in a week and 41 states had worse weeks than they did a week earlier.

On a per-person basis, cases are being led by North Dakota, South Dakota, Montana and Wisconsin. North Dakota doubled its case count since Sept. 6, and more people died there from coronavirus in the last month than in the rest of the pandemic.

The 16 states setting records for new cases in the latest week were Colorado, Idaho, Illinois, Indiana, Kansas, Kentucky, Minnesota, Montana, Nebraska, New Mexico, North Dakota, Ohio, South Dakota, West Virginia, Wisconsin and Wyoming. Record numbers of deaths were reported in Kansas, North Dakota and South Dakota.

– Mike Stucka

Johnson & Johnson temporarily halts vaccine trial after unexplained illness

Johnson & Johnson’s COVID-19 vaccine trial has been paused due to an unexplained illness in a volunteer, meaning 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

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

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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. 

A COVID-19 vaccine by Election Day? Here are the 3 things that would need to happen, and soon.

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.  

“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. 

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.

Experts: Politics will have a hard time getting in the way of a safe, effective COVID-19 vaccine

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

COVID Vaccine Update as Johnson & Johnson Trial Suffers Setback, Sanofi Aims for Mid-2021 Rollout

There are currently nearly 200 potential COVID-19 vaccine candidates in development, including 42 under clinical evaluation and 151 under pre-clinical evaluation, according to a report by the World Health Organization published on October 2.



a person wearing a costume: A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi's laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.


© Joel Saget/AFP via Getty Images
A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi’s laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.

On Monday, U.S.-based Johnson & Johnson announced a pause on all of its COVID-19 vaccine candidate clinical trials due to an “unexplained illness” in one of its study participants.

French pharmaceutical company Sanofi is hoping to have its vaccine candidate rolled out by mid-next year, according to Olivier Bogillot, its chief executive officer.

“We are in a very concrete environment at the regulatory level. We ourselves have signed a charter with various laboratories so as not to compromise on the safety of the vaccine. If the vaccine is effective and it is safe, yes, the next year, in mid-year, the French will be able to be vaccinated,” Bogillot said Tuesday.

Last week, U.S. Secretary of Health and Human Services Alex Azar said: “Pending FDA [Food and Drug Administration] authorizations, we believe we may have up to 100 million doses by the end of the year—enough to cover especially vulnerable populations—and we project having enough for every American who wants a vaccine by March to April 2021.”

The First Phase 3 Clinical Trial Of A Coronavirus Vaccine In The US Has Begun

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Here we take a closer look at some of the latest COVID-19 vaccine developments.

France

Last month, Sanofi and U.K.-based GlaxoSmithKline (GSK) announced they has begun a clinical trial of their COVID-19 vaccine candidate, aiming to reach a phase-three trial by December.

“The companies initiated a Phase 1/2 study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year,” Sanofi confirmed in a statement last month.

“If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.”

U.S.

Johnson & Johnson

Johnson & Johnson, whose vaccine candidate JNJ-78436735 is being developed by Belgium’s Janssen Pharmaceutical Companies, announced: “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.

“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.

“Adverse events—illnesses, accidents, etc.—even those that are

Johnson & Johnson pauses COVID vaccine trial over sick participant

Washington — Johnson & Johnson said Monday that it had temporarily halted its COVID-19 vaccine trial because one of its participants had become sick.



a woman with her mouth open: nurse giving a woman a vaccine injection.jpg


© Johnson & Johnson
nurse giving a woman a vaccine injection.jpg

“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement.

The pause means the enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.

J&J said that serious adverse events (SAEs), such as accidents or illnesses, are “an expected part of any clinical study, especially large studies.” Company guidelines allow them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.



a group of people standing in front of a crowd: Doctor prefers masks to vaccine right now 00:45


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Doctor prefers masks to vaccine right now 00:45

The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the U.S. and around the world, the company and the U.S. National Institutes for Health (NIH), which is providing funding, said.

FDA coronavirus vaccine guidelines raise doubts over approval by Election Day

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The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

J&J was the tenth maker globally to conduct a Phase 3 trial against COVID-19, and the fourth in the U.S. The U.S. government has given J&J about $1.45 billion in funding under Operation Warp Speed to develop its vaccine candidate.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

J&J used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.



a person preparing food in a kitchen: Is a coronavirus vaccine possible in 2020? 07:53


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Is a coronavirus vaccine possible in 2020? 07:53

Pre-clinical testing on rhesus macaque monkeys that were published in the journal Nature showed it provided complete or near-complete protection against virus infection in the lungs and nose. Like several other Phase 3 trials that are underway, its primary objective is to test whether the vaccine can prevent symptomatic COVID-19.

In September, trials on the coronavirus vaccine developed by AstraZeneca and Oxford University were paused after a U.K. volunteer developed an unexplained illness.

The vaccine is one of the most advanced Western projects, having already been tested on tens of thousands of volunteers worldwide. Trials resumed earlier this month in Japan but not the United States, where AstraZeneca is still working with regulators.

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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 pauses clinical trials for a Covid vaccine over patient illness

Johnson & Johnson has paused its clinical trials for a Covid-19 vaccine following a patient illness, just weeks after it announced it was in its final stage.

A pause is not entirely unexpected in vaccine trials. When another vaccine trial was temporarily stopped last month, experts hailed the move, pointing to it as an example of the scientific rigor that is being maintained despite the understandably intense public interest for a Covid-19 vaccine.

The Johnson & Johnson trial was paused after an “unexplained” illness in one of its participants and in compliance with regulatory standards, the company said in a news release Monday night. The pharmaceutical company said the patient’s condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board.

“We must respect this participant’s privacy,” the company’s statement said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

It’s unclear whether the patient received the experimental vaccine or were in the placebo-control group.

AstraZeneca also started its Phase 3 vaccine trial last month but was placed on pause in the U.S. after a participant in the United Kingdom was reported to have developed a spinal cord injury. The company resumed its trial with Oxford University in the U.K. but was awaiting Food and Drug Administration approval to continue in the U.S.

Dr. Francis Collins, director of the National Institutes of Health, told NBC News last month that the pause should reassure those with concerns about possible vaccine safety issues.

“If anybody thinks we’re just glossing over these kinds of issues in the big rush to approve a vaccine, this ought to be reassuring,” Collins said during a “Doc to Doc” interview with NBC News medical correspondent Dr. John Torres, which was streamed on Facebook.

Pfizer and Moderna also have vaccine trials that went into Phase 3 in July, both of which require two doses about a month apart. The Johnson & Johnson vaccine is instead administered in one dose, avoiding the complicated coordination to require that people return in time for the second dose.

Johnson & Johnson announced last week that European Commission approved an advance purchase agreement from its parent company, Janssen Pharmaceutical Companies, for 200 million doses of the vaccine to E.U. member states following approval. The company also said it was looking to allocate up to 500 million vaccine doses toward international efforts for low-income nations.

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