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On Thursday, the European Medicines Agency gave the EMA its first result of the investigation into a suspected side effect of the Astra Zeneca vaccine. The EMA cannot confirm that the condition is due to vaccination and emphasized Thursday that the benefits of the Astra Zeneca vaccine outweigh the risks.
– We have come to a clear conclusion: this is a safe and effective vaccine, said Emer Cooke, head of the EMA safety committee, on Thursday.
However, there are so many indications that the cases are related to the vaccine that the EMA has decided that a warning should be added to the product description of Astra Zeneca’s covid-19 vaccine.
The warning refers to an unusual form of a bleeding disorder that has caused smaller blood clots in various blood vessels, often in the brain, along with a lack of platelets that can lead to bleeding.
By March 16, about 20 cases of bleeding disorder had been reported, out of about 20 million people who received the Astra Zeneca vaccine. The EMA has examined seven cases in Germany, three in Italy, two in Norway and one in Spain, three cases in the UK and two in India.
Since then, more cases have been reported. Among other things, five in Germany, three in Norway, one in Denmark and one in Sweden. In Sweden, it is a woman from Lund, who died this week. Another suspected case is being investigated in Sweden.
What happens in the body?
The Medical Products Agency describes the condition as a bleeding disorder, such as a blood clot in combination with low levels of platelets (thrombocytopenia) and sometimes bleeding. People have gotten sick for up to two weeks after vaccination.
The Medical Products Agency believes that there are similarities between the symptoms and the condition of heparin-induced thrombocytopenia (HIT). Petter Brodin, a Karolinska Institutet physician and researcher with specialized knowledge of the body’s immune system, also sees similarities to antiphospholipid syndrome, an unusual syndrome that is more common among women than men.
Both antiphospholipid syndrome and HIT cause disorders of the blood clotting system. HIT is a drug-induced condition and antiphospholipid syndrome can, among other things, affect people with SLE, a chronic and inflammatory disease.
– The coagulation system reminds the immune system, it is about balance. If you lean in one direction, blood clots and strokes form, if you lean in the other direction, you bleed out. We need to have that balance at all times and when it gets upset it quickly becomes very serious, says Petter Brodin.
A research group in Norway claims to have made findings that support the theory that it is the vaccine that has caused the condition. According to the researchers, the vaccine has created an antibody that has caused the bleeding disorder. A German research group has conducted its own studies and obtained similar results, according to the Wall Street Journal. Both studies are in an early stage. Researchers still don’t understand why antibodies form and react the way they do.
Who has been affected?
Women, and especially younger women, are overrepresented among the reported cases. The overrepresentation could be because they have been vaccinated to a greater extent with Astra Zeneca. In much of Europe, the vaccine was initially used only in younger people, due to a lack of evidence about its effectiveness in the elderly. Therefore, it has largely been given to health and care personnel, where more women than men work.
But there is more evidence that younger women are at higher risk for bleeding disorders. In the UK, fewer cases of the suspected side effect have been reported, despite more people having received the vaccine. The UK has administered the vaccine primarily to the elderly.
– If I am to speculate, it is most likely that it is different populations that receive the vaccine. We know that the Astra Zeneca vaccine is mainly given to elderly patients in the UK and therefore if young women are at higher risk it is reasonable that we see more cases in the EU than in the UK said EMA director of analysis Peter Arlett on Thursday
Based on what so far It is known that most cases have been reported in Norway, in terms of population. Three of the five Norwegian cases concern health workers who have been treated at Rikshospitalen in Oslo.
Petter Brodin has a hard time seeing what the many cases in Norway may be due to, but he doesn’t think other countries have overlooked the cases of the alleged side effect.
– It’s very strange, I agree. But if this is as related to antiphospholipid syndrome as it sounds, then no patient is lost. You get really sick, says Petter Brodin.
Sören Andersson, unit manager for the Swedish Public Health Agency, also sees no reasonable reason for Norway to have more cases.
– It is a warning flag for us and may indicate that we will also have more cases in Sweden. Norway has administered as many doses of Astra Zeneca as we have and we know of nothing that will make the situation in Norway worse, says Sören Andersson.
Could it be more than just a side effect?
Bleeding disorders of this type are rare, says Petter Brodin. However, there may be other explanations besides that it is a side effect of the vaccine.
– When it comes to such small numbers, it can also be a coincidence. That is what is so difficult, he says and continues:
– But if you are going to speculate, you can imagine that the vaccine activates the immune system that has this reaction, but that it is not the vaccine itself that causes it. Things can happen when you tickle the immune system, regardless of how it is done. Prolonged activation of the immune system can trigger reactions and Covid itself is a great example. We have seen many strange conditions among those who have been ill, which may not be directly related to the disease.
Is it treatable?
Several people have died from the presenting symptoms. In addition to Sweden, deaths have occurred in Norway, Denmark, and Germany, among others. But the condition can be cured.
– It is treated trying to support the blood coagulation system. If the patient has clots, a clot buster is administered, but it is an incredibly fine balancing act with this type of condition. In principle, it is impossible to fully control the coagulation system, from the outside as a doctor. There is always the risk of the system falling over the edge. So I should have great respect for this, says Petter Brodin and continues:
– It is important to overcome the emergency condition, if you do, there are good chances of recovery.
Robert Klamroth, vice president of the Association for Thrombosis and Haemostasis Research in Germany, says the reaction they have found can be treated with a combination of anticoagulants and antibodies, which attack the antibodies causing the reaction.
Andreas Greinacher, who leads the German study, says that no one should be afraid to take the Astra Zeneca vaccine.
– Very, very few will develop these problems. But if they do, we now know how to treat patients, he said at a news conference Friday, according to the Wall Street Journal.
Read more:
Finland stops Astra Zeneca vaccine
Germany to use Astra Zeneca vaccine again
More people will receive the first dose of the vaccine; the second dose will be delayed
