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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. 
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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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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.

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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.

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 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.



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“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.



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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.

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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.



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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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