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.
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.