COVID-19

Johnson & Johnson pauses Covid-19 vaccine trial – Full Report

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

Pharmaceutical company Johnson Johnson announced Monday that it is suspending its COVID vaccine trial in the UK after one of the volunteers was diagnosed with an unexplained illness. AstraZeneca PLC said Tuesday that it has suspended a trial of a vaccine involving participants in a British trial of unexplained diseases. Johnson & Johnson said Monday that it had waited for the study to evaluate the participants’ disease before adding more doses. AstraZeneca confirmed today that it has suspended a trial of the CO VID-19 vaccine, developed at Oxford University, until an independent committee can investigate an “unexplained illness” in British participants, following media reports yesterday. [Sources: 2, 7, 9, 10]

If the vaccine proves safe and effective, Johnson & Johnson says it expects to receive the first dose in early 2021. In a conference call with reporters, Dr. John W. Smith, chief medical officer of the Johnson and Johnson Clinic, said the phase 3 trial had begun in the United Kingdom, and the first participants received doses on Wednesday. [Sources: 8]

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No negative events are expected in the Johnson & Johnson group, which will have 60,000 people at full enrollment. In a conference call with reporters Tuesday, he said the timetable for a final interpretation of the vaccine would depend in part on events during the trial. The impact of this investigation could be serious for the future of vaccination programs, “he said in an email to ABC News. Durbin said it is good clinical practice to study the safety of a vaccine before it is given to more people. [Sources: 8, 10, 13]

Nine vaccine candidates are currently in phase 3 trials and AstraZeneca was the first to announce the pause. The promising vaccine candidate, developed by researchers at Oxford, had been marching ahead for more than a year before the voluntary hiatus was announced on Tuesday night. [Sources: 13, 14]

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BBC News reports that the trial was only allowed to continue for a few days after one participant’s illness was diagnosed and found to have nothing to do with the vaccine that was eligible for the candidate. The Oxford-AstraZeneca trial was halted in October 2014 after it was developed into a vaccine that could have caused a serious neurological condition. It was later developed in a separate study at Oxford University, which turned out to be the source of a vaccine that researchers said had nothing to do with the disease. AstraZeneca halted the vaccine’s phase 3 trial in the US and Europe to investigate the case. [Sources: 0, 5, 10]

BBC News reports that the trial was allowed to continue for just a few days after one participant was diagnosed with the disease and found to have nothing to do with the vaccine candidate. The second phase III vaccine trial to be suspended in the US is the trial of the AstraZeneca vaccine. [Sources: 9, 11]

Rush University Medical Center has suspended enrollment for the clinical trial while sponsor AstraZeneca investigates an unexplained condition in a participant. [Sources: 1]

Such breaks are not uncommon in vaccine trials, and are described by sponsors as whenever a potentially unexplained disease occurs in a trial being investigated to ensure the integrity of the trial. Johnson & Johnson’s candidate is being studied as a single vaccine designed to speed up results, while other vaccine candidates require two doses, Stoffels said. The human adenovirus technology used in the vaccine is also being used by Johnson and Johnson in an Ebola vaccine approved by the European Commission. It is technically possible that if there is strong evidence that the vaccines work before trials are complete, DSMB could recommend stopping vaccination so more people can get them, said Dr. Michael O’Brien, director of clinical trials at the U.S. Centers for Disease Control and Prevention. [Sources: 1, 4, 8]

The company did not provide details on the nature of the disease and did not confirm whether the vaccine pause will allow for a safety review. The company said during the call that the trial was suspended in July when a participant had neurological symptoms that were later linked to multiple sclerosis, but not the vaccine. Swiss researchers suspended a study last year after participants in a study in the country reported mild joint pain. Clinical trials conducted by Janssen Pharmaceutical Company have guidelines that allow trials to be interrupted if unforeseen severe adverse reactions (SAE) are detected in relation to a vaccine and there is a careful review of medical information, the company said. [Sources: 2, 3, 9]

On Tuesday, the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) issued a joint statement vowing not to release a vaccine until safety has been proven safe through rigorous testing. They said the dose of the vaccine candidate given in the phase 2 clinical trial of the COVID-19 multiple sclerosis vaccine is too high for health authorities to require an official suspension. The dose was selected for the Phase 2 trial to “accelerate the development of a safe, safe and effective vaccine” for CoVID 19 and to demonstrate the safety profile of vaccine candidates. Therefore, there is no evidence to predict the vaccine’s efficacy and safety, as well as its vectoring ability to predict the immune response elicited from the vaccine in this study. [Sources: 6, 11, 12]

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