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.
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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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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