Stop by AstraZeneca: The most important answers

Christiane Fux studied journalism and psychology in Hamburg. The experienced medical editor has been writing magazine articles, news and factual texts on all conceivable health topics since 2001. In addition to her work for, Christiane Fux is also active in prose. Her first crime novel was published in 2012, and she also writes, designs and publishes her own crime plays.

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After vaccination with the AstraZeneca vaccine, severe thrombosis occurred in individual cases and some vaccinated persons died. Now the European Medicines Agency (EMA) has to determine whether it was a coincidental meeting - or whether the vaccination was actually the trigger. This also requires reassessing whether the benefits of the vaccination still outweigh the risks. What do we know about the incidents so far and do vaccinated people have to worry? Here you can read the answers to the most important questions.

Thromboses, for example in the leg veins, are not uncommon. Within a year, around one in 1,000 people suffers from such a vascular occlusion from a blood clot. It would therefore not be surprising that they also occur in temporal connection with vaccinations such as that of AstraZeneca.

However, it has now become known that the incidents in connection with the AstraZeneca vaccine are an otherwise rare, particularly dangerous form of cerebral vein thrombosis combined with a lack of blood platelets and bleeding. In this country, three vaccinated people died from it. That is why Germany, like other EU countries before, has decided to suspend vaccinations with AstraZeneca for the time being. It thus followed the current assessment of the Paul Ehrlich Institute (PEI).

Why is?

In close proximity to the vaccinations with the vaccine from the manufacturer AstraZeneca, particularly dangerous thromboses were found in vaccinated persons in various European countries. These were certain clots in the brain called sinus vein thromboses, which are usually very rare. They are often associated with a lack of blood platelets (thrombocytopenia).

Typically, such a cerebral vein clot affects an estimated one in 100,000 people annually. In Germany, six cases of such cerebral vein thrombosis and another case of cerebral haemorrhage due to a lack of blood platelets and thrombosis have been reported in vaccinated persons since the start of vaccinations in February. Three of the people affected died.

As reported by the Paul Ehrlich Institute (PEI), there were statistically significantly more cases of cerebral vein thrombosis than normally occur in the population without vaccination. One case would have been expected.

"All the experts were unanimously of the opinion that a pattern can be seen here," says the PEI statement. A connection between the reported cases and the AstraZeneca vaccination is not implausible.

The European Medicines Agency (EMA) is currently examining the cases.

Who is affected?

All incidents occurred between 4 and 16 days after vaccination with the AstraZeneca vaccine. The seven people affected are between 20 and 50 years old. Almost all of them are female:

As reported by the Paul Ehrlich Institute, six women between the ages of 22 and 48 in Germany developed clots in the brain, so-called cerebral sinus and vein thrombosis (CSVT), 6 to 16 days after the vaccination - two of them with fatal outcome. Those affected thus all belonged to the proportionally smaller group of younger vaccinated persons.

In fact, this particular form of thrombosis usually occurs predominantly in women - especially during pregnancy and in women using hormonal contraceptives or hormone replacement therapy.

There was also an incident involving a male vaccinated person. He died of the consequences of a cerebral hemorrhage in connection with an unusual coagulation disorder.

A reduction in the number of blood platelets was also found in some of the seven patients.

How high is the risk?

Since the start of vaccination with AstraZeneca in the spring, 1.6 million doses of the vaccine have been inoculated in Germany. Seven cases of cerebral vein thrombosis occurred over time. Even if the vaccinations caused the incidents, the mathematical risk of such a brain thrombosis based on the previous data would be around 1 in 220,000 - the side effect would therefore be extremely rare.

In the UK, there were only three cases of cerebral vein thrombosis after 11 million AstraZeneca vaccinations.

In addition, the vaccine has already been vaccinated in millions more people worldwide without any complications being observed.

Why do some countries continue to vaccinate?

If the vaccinations are suspended, the probability is high that significantly more people will die from Covid-19 than from possible clots as a result of a vaccination (the average risk of death for Sars-CoV-2 infected people in Germany, for example, is 1.8 percent). This is why Great Britain, Austria and Australia, for example, continue to vaccinate the AstraZeneca vaccine on a large scale.

"Even if the vaccination should be the main cause of the thrombosis or the coagulation disorder, it was still an extremely rare side effect that is far outweighed by the advantages of the vaccination," writes the Paul Ehrlich Institute.

What does this mean for people who have already been vaccinated?

Vaccination damage usually shows up within a few days or weeks after vaccination. This was also the case with the cases of sinus vein thrombosis that have occurred.

The Paul Ehrlich Institute currently recommends people who have had an AstraZeneca vaccination more than 4 and less than 16 days ago to seek medical treatment if they feel increasingly unwell.

This applies in particular to persistent headaches that do not respond to medication and punctiform hemorrhages (petechiae) in the skin, especially on the extremities. The latter may indicate a reduced number of blood platelets (thrombocytes), as seen in some patients with sinus vein thrombosis. Heavy nosebleeds are also a possible consequence.

The most common symptoms of a sinus vein thrombosis are headaches, seizures and neurological deficits such as visual disturbances, and later paralysis.

In contrast, flu-like vaccination reactions such as fever and redness at the vaccination site, but also headaches that occur in the first few days after the vaccination and then subside again, are no cause for concern.

Are vaccination appointments canceled?

AstraZeneca vaccine will no longer be inoculated in Germany until the final assessment by the European Medicines Agency (EMA). The vaccination appointments - both first and second vaccinations - are usually canceled for the time being. However, some federal states could decide to have a replacement vaccination with one of the other approved vaccines.

What's next?

Once the research is complete, the European Medicines Agency will make a final assessment of the benefit-risk profile of the vaccine. This assessment determines whether the vaccine will retain its approval and whether it can continue to be used. Since healthy people are vaccinated, the safety requirements for vaccines are particularly high. The Paul Ehrlich Institute writes that the first result can be expected this week.

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