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Norway ‘disagreed’ with EMA conclusion over AstraZeneca vaccine

Norwegian officials disagreed with the EMA's decision not to list cases of blood clots as possible side effects of the AstraZeneca vaccine, according to a media report in the Nordic country.

Norway 'disagreed' with EMA conclusion over AstraZeneca vaccine
Photo: MIGUEL RIOPA / AFP

The Norwegian Medicines Agency (NOMA) believes that there is enough reason to assume that there is a causal link between the vaccine and cases of blood clots, newspaper VG reports.

“Norway believes that there is reasonable cause to assume that there is a causal relationship, therefore we would have liked this disease description to be included in the list of possible side effects. When that didn’t happen, we took issue with the overall package,” Sigurd Hortemo, chief physician at the department of drug information at NOMA told VG.

The European Medicines Agency (EMA) concluded on Thursday that the AstraZeneca vaccine was a “safe and effective” tool in the battle against Covid-19 but its investigation could not rule out whether the jab had caused rare cases of blood clotting.

Norway has gone against the EMA conclusion by continuing the pause the use of AstraZeneca in its vaccination programme. A decision on whether use of the drug will resume will be made no earlier than next week.

According to an assessment by the side effects committee at the EMA (PRAC), a warning should be included with a description of symptoms in the drug description with advice to patients and doctors, but new possible side effects of the vaccine would not be listed, VG writes.

A group of medical experts at Oslo University Hospital said on Thursday that blood clots in three health workers who took the AstraZeneca vaccine were triggered by an immune system response to the vaccine.

READ ALSO: Norwegian experts conclude ‘strong immune response’ from AstraZeneca vaccine linked to blood clots

“We haven’t completely arrived with (inclusion) of our view, you can say, but we have made progress in that you can see that the drug description describes symptoms that have occurred in association with the vaccination. And there is also assurance that this will be followed up on,” Hortemo said.

He added that he was pleased that there would be such a description, which will be contained in packaging enabling doctors and patients to consider it, but that Norway could not agree with the “final package” of the EMA decision.

The committee had decided to add a warning but not include the symptoms on a list of possible side effects, he explained according to VG.

“That means PRAC has concluded there is not a strong enough connection,” he said. That would appear to oppose the conclusions of the Norwegian expert group.

Are Stuwitz Berg, head of vaccines against preventable diseases at the Norwegian Institute of Public Health (NIPH) noted that EMA’s assessment is a preliminary one.

“They will continue their investigations. I expect to hear more from the EMA,” he told VG.

He also added that the situation may change as the EMA carries out further investigations.

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EUROPEAN UNION

Norway flirts with the idea of a ‘mini Brexit’ in election campaign

On paper, Norway's election on Monday looks like it could cool Oslo's relationship with the European Union but analysts say that appearances may be deceiving.

Norway flirts with the idea of a 'mini Brexit' in election campaign
The Centre Party's leader Slagsvold Vedum has called for Norway's relationship with the European Union to be renegotiated. Photo: Gorm Kallestad / NTB / AFP

After eight years of a pro-European centre-right government, polls suggest the Scandinavian country is headed for a change of administration.

A left-green coalition in some shape or form is expected to emerge victorious, with the main opposition Labour Party relying on the backing of several eurosceptic parties to obtain a majority in parliament.

In its remote corner of Europe, Norway is not a member of the EU but it is closely linked to the bloc through the European Economic Area (EEA) agreement.

The deal gives Norway access to the common market in exchange for the adoption of most European directives.

Both the Centre Party and the Socialist Left — the Labour Party’s closest allies, which together have around 20 percent of voter support — have called for the marriage of convenience to be dissolved.

“The problem with the agreement we have today is that we gradually transfer more and more power from the Storting (Norway’s parliament), from Norwegian lawmakers to the bureaucrats in Brussels who are not accountable,” Centre Party leader Trygve Slagsvold Vedum said in a recent televised debate.

READ ALSO: 

Defending the interests of its rural base, the Centre Party wants to replace the EEA with trade and cooperation agreements.

However, Labour leader Jonas Gahr Store, who is expected to become the next prime minister, does not want to jeopardise the country’s ties to the EU, by far Norway’s biggest trading partner.

“If I go to my wife and say ‘Look, we’ve been married for years and things are pretty good, but now I want to look around to see if there are any other options out there’… Nobody (in Brussels) is going to pick up the phone” and be willing to renegotiate the terms, Gahr Store said in the same debate.

Running with the same metaphor, Slagsvold Vedum snapped back: “If your wife were riding roughshod over you every day, maybe you would react.”

EU a ‘tough negotiating partner’

Initially, Brexit gave Norwegian eurosceptics a whiff of hope. But the difficulties in untangling British-EU ties put a damper on things.

“In Norway, we saw that the EU is a very tough negotiating partner and even a big country like Britain did not manage to win very much in its negotiations,” said Ulf Sverdrup, director of the Norwegian Institute of International Affairs.

While Norwegians have rejected EU membership twice, in referendums in 1972 and 1994, a majority are in favour of the current EEA agreement.

During the election campaign, the EU issue has gradually been pushed to the back burner as the Centre Party — which briefly led in the polls — has seen its support deflate.

The nature of Norway’s relationship to the bloc will depend on the distribution of seats in parliament, but experts generally agree that little is likely to change.

“The Labour Party will surely be firm about the need to maintain the EEA agreement,” said Johannes Bergh, political scientist at the Institute for Social Research, “even if that means making concessions to the other parties in other areas”.

Closer cooperation over climate?

It’s possible that common issues, like the fight against climate change, could in fact bring Norway and the EU even closer.

“Cooperation with the EU will very likely become stronger because of the climate issue” which “could become a source of friction” within the next coalition, Sverdrup suggested.

“Even though the past 25 years have been a period of increasingly close cooperation, and though we can therefore expect that it will probably continue, there are still question marks” surrounding Norway’s future ties to the EU, he said.

These likely include the inclusion and strength of eurosceptics within the future government as well as the ability of coalition partners to agree on all EU-related issues.

Meanwhile, Brussels is looking on cautiously. The EEA agreement is “fundamental” for relations between the EU and its
partners Norway, Iceland and Liechtenstein, according to EU spokesman Peter Stano.

But when it comes to the rest, “we do not speculate on possible election outcomes nor do we comment on different party positions.”

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