The AstraZeneca vaccine – – It would be very, very sad

– How serious is it if these cases of disease continue to occur at the rate we see now?

– It would be very, very sad. I just sincerely hope this stops now.

Audun Hågå, director of the Norwegian Medicines Agency, does not hide that he is concerned about the future of the AstraZeneca vaccine in Norway, after a total of six serious cases of the vaccine, two with fatal outcomes, have been recorded.

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-These are dramatic days, emphasizes Dagbladet.

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At Thursday’s press conference with the Norwegian Medicines Agency and the National Institute of Public Health (NIPH), it was revealed that the approval for the AstraZeneca vaccine remains, but that health authorities are monitoring the situation closely. The self-imposed temporary cessation of vaccination continues for at least one week.

– We believe that we should do more thorough investigations, analyze the causal connection between these serious cases, give ourselves more time before concluding here in Norway, FHI chief physician Are Berg tells Dagbladet.

It was also announced today that the European Medicines Agency (EMA) is giving the green light for the continued use of the controversial vaccine. But ultimately, it is Norway itself that decides whether it should be handed over to the population.

Hours earlier, the Rikshospitalet research team, led by Professor and Chief Physician Pål André Holme, announced that they believe they have discovered the mechanism that causes patients to have blood clots, bleeding and low platelet content: the body’s immune system stimulates the production of antibodies. that triggers the symptoms.

Holme does not want to say with certainty that the AstraZeneca vaccine is the cause, but it remains the main suspect, since it is the most conspicuous common denominator among all patients. Second, the combination of symptoms is very rare.

Sensational Norwegian figures

Patients vaccinated with the course of the disease have also been registered abroad, such as in Norway, but Hågå at the Norwegian Medicines Agency notes that the number in this country is alarming.

– They are very many, compared to those we have vaccinated in Norway, compared to other countries. There it varies a lot and is strange. But in some countries there are no cases, while in other countries some are now beginning to appear, but far from those we have in Norway for vaccinated, he tells Dagbladet.

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– Do you have any idea why this is so?

– It is very difficult to say, but what we can establish is that Norway is a small and clear country, with quite good systems. The advantage is that when such special things appear, they meet in a hospital, Rikshospitalet, and then perhaps it is faster to find out in Norway that there is something here, rather than other large countries, where these cases can spread and that it may take time before I start to see connections. But that is pure speculation.

Hågå does not believe that the conditional approval of the AstraZeneca vaccine will be withdrawn.

– But it is FHI that is considering if they want to use it in the Norwegian population, says the Directorate of Medicines and recalls that FHI must return with a plan in a week, since a week ago they put the vaccine on hold for 14 days.

You can separate the group

According to chief physician Are Berg at FHI, it’s hard to say how overwhelming data sets might be needed for the institute to change the recommendation for the AstraZeneca vaccine.

– We are still in a relatively early stage. There are many reasons to suspect this connection: is it related to special groups in society, how sure can we be that the symptoms are related to vaccination? he tells Dagbladet.

– Can it be relevant to separate a group that reacts to the vaccine and continue vaccinating the rest of the population?

– There will always be an alternative – compare at the beginning, as we were not sure enough about the effect of the AstraZeneca vaccine in the older age groups. This will also be the case if we think that we can use the vaccine in some and not all sectors of the population. There is still some speculation, Berg says.

– On the relationship of trust in the population: When does the cost / benefit ratio change to the fact that using a vaccine with serious side effects costs too much?

– It is a difficult question. We based the first breakout on a slightly thinner foundation than we think we have now, as there have been several instances. We believe that clearly showing that we do extensive investigations when this suspicion has arisen is the most reliable thing we can do, says Berg, emphasizing:

– But of course: what I would have had the most confidence would have been that this had not happened, that we could continue vaccinating without these serious cases appearing.

– Impossible to detect

Berg emphasizes that all vaccines have undergone a phase 3 study, in which the drugs are tested in tens of thousands of people, some of whom receive placebo. But it also emphasizes that it is impossible to detect all the rare side effects.

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– It is the case that very rare side effects like this do not usually appear until the vaccine has begun to be used in millions of people, says the superior.

Around 130,000 people have received the AstraZeneca vaccine in Norway. Berg emphasizes that a lot of work remains before we can determine how often we can expect to see serious side effects.

– So far we have reported these six cases, but we do not know if there are more, and we do not know if they are all exactly the same – and do they have the same characteristics? So here we have to wait for what the rest of Europe finds in its records and monitoring systems, he says.

– Very good effect

– How unfortunate is it that the AstraZeneca vaccine is being withdrawn from circulation in Norway?

EU says yes, Norway is waiting

– It does not have dramatic consequences, but of course it will delay us. Now we only have one break so far, and that has little to say in the end. But if we decide to completely remove it from the program, in the end there will be a few weeks of delay.

– How to maintain confidence in the vaccine?

– First of all, we must map this well and know what it is and what kind of causal connection we are facing. So we must be able to speak very clearly and well about it, both in Norway and internationally, says Berg.

– That is why it is very important to remember that the vaccine also has a very good effect and protects against serious disease. Especially in the world, where the infection situation is much worse. Some countries do not want to resort to other vaccines either.