- International company Johnson & Johnson said one of the participants developed an "unexplained illness" after receiving the dose
- The drugmaker, however, said that such cases were expected but noted that it was investigating whether the case was a coincidence or linked with the jab
- Johnson & Johnson becomes the second company to pause trials after AstraZeneca in September 2020
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US-based drugmaker Johnson & Johnson has temporarily paused rolling out of the third trial phase of a Covid-19 vaccine it has developed.
The company announced on Monday, October 12, that it made the decision following what it termed as "an unexplained illness" in one of the volunteers.
Johnson & Johnson is conducting the trials in at least 60 000 people, making it one of the largest populations to be inoculated with the experimental dose.
According to the firm, its researchers were reviewing the case to establish whether it was a coincidence or it was related to the jab.
It, however, stated that such occurrences were expected in vaccine trails especially those that involve a fairly large population.
"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 serious, are an expected part of any clinical study, especially large studies. 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.
"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.
Johnson & Johnson became the second company to pause trials after AstraZeneca in September 2020.
The AstraZeneca vaccine trial was paused after a subject in Britain developed complications. The study continued in Britain and other countries but it was paused in the US to allow medics to examine the development.
Moderna/NIH and BioNTech/Pfizer are among companies that have their advance trials that started in July 2020 underway.
The two pauses come at a time when the race for a vaccine has continued to gain steam with US President Donald Trump insisting that the country will have a safe dose before the November 3 presidential election.
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