Norway health official counters AstraZeneca over vaccine safety statement

Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), has criticised Covid-19 vaccine supplier AstraZeneca over a statement related to cases of blood clots in vaccinated people.

Norway health official counters AstraZeneca over vaccine safety statement
Photo: Vano SHLAMOV / AFP

Norwegian health officials have reported cases of blood clots or brain haemorrhages in younger people who received the AstraZeneca Covid-19 jab, but said they could not yet say they were vaccine-related.

The Norwegian Medicines Agency on Saturday said it had “received several adverse event reports about younger vaccinated people with bleeding under the skin (tiny dots and /or larger blue patches) after coronavirus vaccination.

“This is serious and can be a sign of reduced blood platelet counts,” it said. “Today, we received three more reports of severe cases of blood clots or brain haemorrhages in younger people who have received the AstraZeneca vaccine. These are now receiving hospital treatment,” it added.

Four cases of serious blood clots in vaccinated people have so far been reported in Norway.

A health sector worker who was hospitalised after receiving the vaccine in Norway later died, the Norwegian Medicines Agency and the Norwegian Institute of Public Health (NIPH) confirmed on Monday.

Geir Bukholm, director of Infection Control and Environmental Health NIPH, previously said that following the decision to suspend the jab, it was now “the Norwegian Medicines Agency’s role to follow up on these suspected side effects and take the necessary measures”.

AstraZeneca, an Anglo-Swedish company which developed the vaccine with Oxford University, has defended the safety of its product.

“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca’s chief medical officer Ann Taylor said in a statement.

“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Taylor also said.

Madsen argued against that statement in comments given to Norwegian news agency NTB.

“AstraZeneca does not have the basis to claim these cases are not related to the vaccine,” he said.

“We don’t know whether they have anything to do with the vaccine. But we also do not have the basis for saying they do not have anything to do with the vaccine,” he continued.

The medical director of the Norwegian Medicines Agency called AstraZeneca’s statement “unfortunate”.

He also said in response to the company’s statement that statistics alone were not sufficient to rule out any connection.

The large numbers involved, given the amount of doses of the AstraZeneca vaccine already administered, do not point to a connection between the cases and the vaccine.

“But then you have isolated cases, like these four cases in Norway, which have very particular disease situations. There is another way to conduct monitoring of medicines,” Madsen said.

“They will never stand out in statistics because they are so few. But because they are so serious for those they affect, we have to investigate whether they can have any connection to the vaccine,” he added.

READ ALSO: Norway to receive up to one million fewer doses of AstraZeneca vaccine

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Could Oslo-Copenhagen overnight train be set for return?

A direct overnight rail service between the Norwegian and Danish capitals has not operated since 2001, but authorities in Oslo are considering its return.

Norway’s transport minister Knut Arild Hareide has asked the country’s railway authority Jernbanedirektoratet to investigate the options for opening a night rail connection between Oslo and Copenhagen.

An answer is expected by November 1st, after which the Norwegian government will decide whether to go forward with the proposal to directly link the two Nordic capitals by rail.

Jernbanedirektoratet is expected to assess a timeline for introducing the service along with costs, market and potential conflicts with other commercial services covering the route.

“I hope we’ll secure a deal. Cross-border trains are exciting, including taking a train to Malmö, Copenhagen and onwards to Europe,” Hareide told Norwegian broadcaster NRK.

The minister said he envisaged either a state-funded project or a competition awarding a contract for the route’s operation to the best bidder.

A future Oslo-Copenhagen night train rests on the forthcoming Jernbanedirektoratet report and its chances of becoming a reality are therefore unclear. But the Norwegian rail authority earlier this year published a separate report on ways in which passenger train service options from Norway to Denmark via Sweden can be improved.

“We see an increasing interest in travelling out of Norway by train,” Jernbanedirektoratet project manager  Hanne Juul said in a statement when the report was published in January.

“A customer study confirmed this impression and we therefore wish to make it simpler to take the train to destinations abroad,” Juul added.

Participants in the study said that lower prices, fewer connections and better information were among the factors that would encourage them to choose the train for a journey abroad.

Norway’s rail authority also concluded that better international cooperation would optimise cross-border rail journeys, for example by making journey and departure times fit together more efficiently.

The Femahrn connection between Denmark and Germany, currently under construction, was cited as a factor which could also boost the potential for an overland rail connection from Norway to mainland Europe.

Night trains connected Oslo to Europe via Copenhagen with several departures daily as recently as the late 1990s, but the last such night train between the two cities ran in 2001 amid dwindling demand.

That trend has begun to reverse in recent years due in part to an increasing desire among travellers to select a greener option for their journey than flying.

Earlier this summer, a new overnight train from Stockholm to Berlin began operating. That service can be boarded by Danish passengers at Høje Taastrup near Copenhagen.

READ ALSO: What you need to know about the new night train from Copenhagen to Germany