– Says the systems work – VG

The American company Johnson & Johnson announced on Tuesday night that they have put on pause the tests of their potential corona vaccine, which is in phase 3.

The cause was an unexplained illness in one of the 60,000 volunteer participants, the company explained.

“In accordance with our guidelines, the disease is being investigated and evaluated by the independent Data Stability Monitoring Board,” they wrote in a press release.

The EU is among those who have signed an agreement to buy this vaccine for its member countries, and Norway, if it is completed.

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The fact that a participant in a vaccine study is diagnosed with an unexplained disease is not cause for concern, says Gunnveig Grødeland, a researcher at the Department of Immunology and Transfusion Medicine at the University of Oslo.

– What does a break like this really say?

– Says the systems work. If I hadn’t had reports of deviations in phase three of any study, I would have been concerned. So we have to wait until we really know what we have to deal with for a reason, before we can conclude what consequences this breakup has.

Grødeland explains that if the participant’s disease course is severe and can be directly related to the vaccine, it may spell the end of the entire study.

Therefore, Norwegians do not have to be skeptical of a possible future vaccine from the company, says the researcher.

– The vaccine is not ready until it is approved. At any stage before approval, it can be stopped if serious side effects are found. Now they are trying to find out if the side effect is related to the vaccine, he says, adding:

– If it is and is severe, the study will most likely stop completely.

In early September, all trials of another vaccine, the AstraZeneca vaccine, developed in collaboration with the University of Oxford, were suspended following the illness of a participant from the United Kingdom. Later that week, the company announced that the participant had transverse myelitis, which is an inflammation of the spinal cord.

It is not known what type of disease the participant in the Johnson & Johnson vaccine study has.

– Side effects, illnesses, accidents, etc., even serious, are expected in clinical trials, especially large studies, the company writes in its press release.

The vaccine is being developed by the Johnson & Johnson-owned Janssen Pharmaceutical Companies in collaboration with Beth Israel Deaconess Medical Center in the US.

Nakstad: the vaccine may be delayed

– We still do not know if the interruption of the study is due to a side effect or not, nor do we know if the person who got sick received a vaccine or not, the so-called “placebo”, says the deputy director of the Norwegian Health Directorate, Espen Nakstad.

He notes that therefore it is not certain that the break has significant significance for further testing, and sees as good news that the study has now been put on hold, for safety reasons.

– It is first and foremost reassuring that suspected side effects are thoroughly investigated in a study participant.

Nakstad says it is unclear whether this delay will mean it will take longer before a vaccine can be rolled out in Norway.

– Discontinuation may mean that the trial of this particular vaccine will be delayed. It could also happen to some of the other nine vaccine candidates now in the “phase 3 trial,” he says, noting that the AstraZeneca study was delayed only a few weeks when something similar happened to them.

– If such delays really have an impact on the vaccines that the EU finally approves and that Norway has access to, it is too early to say, says Nakstad.

Steinar Madsen is the Medical Director of the Norwegian Medicines Agency. In the end, it will be up to them to decide whether a vaccine should be approved for use in Norway.

– This shows that the security system you have to test drugs and vaccines works, he says.

Like Nakstad, Madsen says the breakup could spell delay.

– But you clearly follow the rules here: when serious side effects occur, it is quite common for you to take a break from the clinical study later, so that you have time to analyze what may be the cause of the possible side effect.

– How does the Norwegian Medicines Agency monitor such study interruptions?

– Now this is a vaccine that is not being tested in Norway, so it is not responsible. We expect the company to share information with pharmaceutical authorities in the US and Europe once they have found out.