Norway took up dissent – VG

– Norway believes that there are reasonable reasons to suppose that there is a causal connection, so we would have liked this condition to be included in the list of side effects. When it didn’t happen, we disagreed with this package overall, Sigurd Hortemo from the Norwegian Medicines Agency tells VG.

At 5:00 p.m., the European Medicines Agency (EMA) held a press conference on the AstraZeneca vaccine. First, EMA Executive Director Emer Cooke delivered a speech, saying that EMA’s conclusion is that AstraZeneca remains an effective and safe vaccine.

Then came the evaluation to the side effects committee (PRAC), that a warning with a description of the disease picture should be included in the drug review, with advice for patients and doctors, but they do not add anything new to the list of possible side effects of the vaccine.

They had then discussed the matter in meetings since Thursday morning. They had not yet finished the meeting when the conclusion was presented at the press conference, but it was clear what the outcome would be, according to Hortemo.

– So you can say that you have not reached our point, but we have come a long way in the sense that the drug review describes that the picture of the disease has occurred in relation to vaccination. And there is also the assurance that it will be closely followed, says Hortemo.

He emphasizes that the Norwegian Medicines Agency is pleased that a description of the condition is included in the medicine review that doctors and patients can relate to, but that Norway could not agree on the final “package”.

This is the difference

If you are going to add something to the list of possible side effects, there must be a reasonable reason to assume there is a connection to the vaccine, Hortemo explains. However, the side effects committee only adds a warning and does not add a new item to the list of possible side effects.

– This means that the PRAC has assessed that you do not have a good enough causal connection, he says.

This is what Norway disagrees with.

He adds that the Norwegian Medicines Agency is excited to see what will happen when other countries review their reports of side effects.

– We think the press release from Germany was illustrative: when they came back and looked at this, they found that they had several of these characteristic cases.

In Norway, only three healthcare workers entered Rikshospitalet with an unusual combination of blood clots, bleeding and a low platelet count after being vaccinated with AstraZeneca. On Thursday, the Norwegian Medicines Agency stated that a total of five vaccinated people in Norway have been admitted with the rare combination.

One of those admitted to the hospital died on Sunday. A group of experts from Rikshospitalet has worked together with the University Hospital of Northern Norway (UNN) to find out what has caused the serious processes of the disease.

They believe that a strong immune response has triggered the system to have a combination of blood clots and low platelets, and that there are no things other than the vaccine that can explain this immune response.

Sabine Straus of the EMA’s side effects committee said at Thursday’s press conference that they have reviewed all the information that was available as of Wednesday and that if there was new information on Thursday, it has not been included. Hortemo has previously said that the Norwegian doctors’ statement was translated into English on Thursday and sent to the Norwegian representatives on the side effects committee.

NIPH: a different assessment in Norway

It is FHI to consider what should be done with the AstraZeneca vaccine in the Norwegian vaccination program. They think it is too early to wrap up now, but they will come back with this next week.

Chief physician Are Stuwitz Berg notes that the EMA has said Thursday’s assessment is preliminary.

– They will continue their investigations. I therefore expect more from the EMA and the European Medicines Agency.

And when Norway gives an answer, they may be considering other things besides what the EMA does, he says.

– Although the infection situation is quite serious, we have a different infection situation than in other countries. We have a pretty good delivery situation for other vaccines, and we have experienced several serious cases that we need to investigate if it can be linked to vaccination, he says, adding:

– The risk assessment on the Norwegian side may seem different from the European perspective, but it can be developed a bit as there is more information from other countries with more cases in the EMA’s subsequent investigations.

At Thursday’s press conference, EMA CEO Emer Cooke said that EMA’s conclusion is that AstraZeneca remains an effective and safe vaccine.

– Do you think they came out too early?

– If you read the press release, maybe they were a little more bombastic at the press conference than there. There they clearly say that they will investigate this further, and that it is an ongoing evaluation, he says.

– Right to wait

Berg notes that there is also an international aspect to this:

– This is an important vaccine in the great international world of vaccines. The Covax collaboration relies heavily on the AstraZeneca vaccine. So if it falls off, it’s dramatic, he says.

– In many countries around the world, a risk assessment will look very different. These very rare cases, if it turns out to be a connection, may have less to say than how many you can save with an effective vaccine.

In this panorama, the EMA is also a European and international organization.

He believes this means that they are already clear that they believe the benefit of the vaccine outweighs the risk. And that FHI concludes that it is correct to continue with the stoppage of AstraZeneca considering the same in Norway.

– From the Norwegian side, we believe that it is correct to wait with a decision.