Saturday, March 20, 2021

The Norwegian Medicines Agency believes that European countries will detect more rare cases of blood clots

Here is a google- translated article from Norway that tells it like it is about the A-Z vaccine, and why it is so hard for there to be transparency.

 Steinar Madsen, medical director at the Norwegian Medicines Agency, believes that several European countries will discover possible side effects of the AstraZeneca vaccine when they start looking more closely. In Norway, we have discovered more of the blood clot cases in relation to the number of vaccinated than in any other country in Europe, according to the Norwegian Medicines Agency.

- Do you fear underreporting in other countries?

- I do not want to say that they underreport, but this is a completely new condition. One just has not been aware of it. When you become aware that this exists, people start looking in different countries, says Steinar Madsen, medical director of the Norwegian Medicines Agency.

He says many more blood clot cases have been discovered in the last week, and refers to Germany, Sweden, Denmark and Austria, among others.

British media, such as The Telegraph, covered five cases in the UK on Thursday. At the same time, the British health authorities point out that the incidence is far lower than what is expected in a normal population, and say the vaccine is safe. 

- Many countries have problems with transparency

Director of the Norwegian Medicines Agency, Audun Hågå, tells NTB that a possible explanation for the fact that Norway has detected more blood clot cases than other countries is that Norway is small and clear. Researchers at OUS have recently investigated three serious cases in which health workers have received a strong immune response .

Madsen says that there is a tradition of openness in this country, and believes this is crucial for trust. Other European countries do not have the same openness, he believes.

Steinar Madsen, medical director at the Norwegian Medicines Agency

Steinar Madsen, medical director of the Norwegian Medicines Agency.


 - Many other countries have problems with transparency, because there is not the same trust in the authorities. Therefore, the authorities are very anxious about unfortunate events, such as that it is said that this is a side effect.

Until the end of next week, the Norwegian health authorities will carefully consider whether to follow the EU and resume the use of the AstraZeneca vaccine in this country. Several countries have resumed vaccination after the EU's green light.

Yesterday, Norway's representative in the side effects committee of the European Medicines Agency (EMA), David Olsen - as the only country - argued that special blood clot cases should be included in the list of possible side effects in the drug review.

The adverse reaction committee came to the conclusion that a warning should instead be included in the drug review for doctors with advice on how to handle the cases.

Medical director Steinar Madsen describes yesterday's EMA meeting as "a bit dramatic". Madsen will not go into detail about what he puts in dramatically, and points out that the countries' representatives should not comment on the meetings in the media.

- We believe there is documentation that this should be included as a side effect, which is quite recognized, Madsen says to NRK.

  •  Violent debate

The matter will be discussed today in the Scientific Committee of the EMA. Normally, this is considered a formality, but there is now a certain tension associated with the outcome.

The EMA's adverse reaction committee concluded yesterday that the AstraZeneca vaccine is safe. The adverse reaction body states that they cannot rule out a connection with blood clot cases, but that the positive side of the vaccine outweighs the risk .

- When you vaccinate millions of people, it is inevitable that serious or rare diseases will occur after vaccination, says EMA CEO Emer Cooke.

Madsen explains that getting the special blood clot cases into the side effect list in the doctors' instructions for use would give an even clearer signal to the doctors that they have a connection with the vaccine.

- What does it tell you that EMA did not want it (the point about side effects)?

- There was a fierce debate about this. Many countries in Europe are in a desperate situation. One reason may be that one is afraid that the reputation of this vaccine will be harmed in a critical situation.

If a vaccine is associated with a side effect, it can lead to people looking at this vaccine differently, Madsen points out.

- Do you think European countries place crucial emphasis on the reputation of the vaccine?

- In Norway we do not do it, but the situation is different in other countries. Norway and the rest of Scandinavia have a slightly different tradition. Maintaining trust in the authority is very important to us in the situation we are in now, says Madsen.

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