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The European Medicines Agency (EMA) has reviewed reports of possible side effects in people who have received the AstraZeneca vaccine. On Wednesday, the EMA stated that 62 cases of rare blood clots in the brain have been registered in newly vaccinated people in the EU and EEA countries.

A total of 258 serious blood clots and 45 deaths have been reported among people who have received the AstraZeneca vaccine.

However, the EMA has not been able to prove any causal link between the AstraZeneca vaccine and the blood clot, but does not deny that there is a link.

– We have evaluated 62 cases out of 9.2 million that have been vaccinated with AstraZeneca. This poses a risk of one per 100,000 vaccinated for those over 60, says EMA Director Emer Cooke.

EMA Director Emer Cooke held a press conference on Wednesday afternoon.

– There is a wide range of different medical expertise that has assessed the cases of blood clots after AstraZeneca. They have looked at whether there are any underlying risk factors in the patients who are affected. But so far they have not been able to establish with certainty that neither age, gender nor underlying physiological or medical factors present a greater risk of such serious side effects.

– There is no evidence that we will stop vaccinating in some parts of the population, Cooke continues.

She adds that the EMA continuously monitors the AstraZeneca vaccine and works closely with the countries that use the vaccine the most.

The EMA’s final conclusion is announced in a week.

The Norwegian Medicines Agency: Seriously

Steinar Madsen, medical director at the Norwegian Medicines Agency, believes it is serious that 62 cases of rare blood clots in the brain have been registered.

He calls the information from the EMA very important data.

– Now we get to know more about who is affected, age and gender. This is important to keep in mind when considering further use. The Norwegian Medicines Agency is now collecting all possible data from different countries to find out as much as possible about it. Is there any way to prevent it, give it to specific age groups, says Madsen.

Steinar Madsen, Medical Director at the Norwegian Medicines Agency.
Photo: Stian Lysberg Solum / NTB

He does not yet know how many of the 62 who have died of blood clots, but calls it very serious that so many have been affected.

Still recommend the vaccine

The EMA still recommends the use of the vaccine and believes that the advantages outweigh the disadvantages.

– Two weeks ago, we came to a preliminary conclusion where we came to the conclusion that the benefits obtained from taking the AstraZeneca vaccine provide greater benefits than the disadvantages associated with side effects. We are still standing there, said director Emer Cooke of EMA at a press conference on Wednesday afternoon.

However, the EMA chief says it is difficult to assess the advantages against the disadvantages of the vaccination. There are many factors that need to be considered, the spread of covid-19 in the population, age, and whether or not anyone works in health care.

Paused in Norway

Several countries, including Norway, have suspended the use of AstraZeneca while it is being investigated whether the vaccine is associated with a rare form of blood clot and low platelet count.

On Tuesday, it became known that 31 cases of blood clots and nine deaths have been registered among vaccinated people in Germany.

The rare course of the disease is described as similar to what has been seen in several cases in Norway, where researchers at Rikshospitalet have concluded that it is probably due to the vaccine.

See the entire EMA press conference.

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