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On Tuesday it was announced that the vaccine candidate of the multinational group Johnson & Johnson has been suspended. The reason is that a test person has contracted a potentially unexplained illness.
The vaccine is in phase 3 of the vaccine development phase, and is in the process of testing what will eventually be up to 30,000 people.
For just over a month, pharmaceutical giant AstraZeneca’s so-called Oxford vaccine also had to be temporarily suspended for the same reason.
However, it is not surprising that incidents like this occur, explains Gunnveig Grødeland, lead researcher from the Department of Clinical Medicine at the University of Oslo.
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– Unexplained illness
– We have decided to temporarily pause the additional dosing in all of our Covid-19 tests, including our phase 3 test. This is because a test person has developed an unexplained illness. According to our routines, the person is followed up and the disease case is further investigated, Johnson & Johnson writes in a news release Tuesday night.
Grødeland, an expert in immune systems, viruses and vaccine development, explains that companies have to stop to find out if it is the vaccine or external factors that create the problem for the person doing the test.
In this case, an “unexplained illness.”
– You try to choose people who do not have underlying diseases, but you can only check what is known before and what is revealed in the medical check-up beforehand, says and continues:
– A large number of participants participate in this study, they hope to recruit 30,000, and then the possibility of some unknown diseases occurring in the participants dramatically increases. Both problems that are actually due to the vaccine and those that are due to entirely different causes, Grødeland tells Dagbladet.
– It must be reasonably safe
The fact that there are so many participants in phase 3 of vaccine development also increases the likelihood that such incidents will occur in this particular phase, Grødeland emphasizes.
In phases 1 and 2, one is much more selective in the selection of candidates.
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She emphasizes that companies do not continue with the development of the vaccine until they know that the vaccine itself was not the cause.
– The company must be reasonably certain that there was no reaction to the vaccine. If it turns out they were wrong, it will have significant negative financial consequences for the company. Therefore, this is carefully investigated, says Grødeland.
He also does not think that the Johnson & Johnson vaccine candidate now on hold is of any significance to when we can expect a vaccine here at home.
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– Now is the second time this has happened with one of the leading candidates in phase 3. But the Oxford vaccine started again shortly after. At the same time, there are ten different vaccine candidates now in phase 3. That hiatus, which is hopefully temporary, doesn’t have to be severe for this or other vaccine candidates.
We’ll be free
According to the director of the FHI department, Line Vold, it is independent of the interruption of the tests of this vaccine, and it is not known when Norway can expect to receive doses of the vaccine across the border.
– It has been speculated if in the best of cases we could get it during the New Year. But it’s uncertain, so here’s a guess on my part. We can’t say anything for sure at this point, Vold told Dagbladet in mid-September.
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Although there will have to be a clear order of priority when a vaccine is first available in Norway, it is not completely clear yet.
– No prioritization order has been completed at this time, we are working on that at FHI. Typically, healthcare workers and risk groups rank high on that list.
During a statement at the Storting on Tuesday, Health Minister Bent Høie announced that the corona vaccine will be free and will be organized as part of the national vaccination program.
The decision was in line with the FHI recommendations.
Høie also reiterated at the Storting that the hope is that the vaccine will arrive early next year.
