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There were seven cases of "sinus vein thrombosis" in the brain that led to a temporary suspension of Covid-19 vaccinations with the AstraZeneca vaccine in Germany.
Six women and one man were affected, three of whom have died so far.
Other individual cases occurred in other European countries - so far three in Great Britain - while the vast majority of the millions vaccinated worldwide did not experience any serious side effects.
“For the very, very, very, very, very most of the people there is no risk,” said Health Minister Jens Spahn on Monday.
However, since scientists cannot rule out a connection with the vaccination, the federal government decided, on the recommendation of the Paul Ehrlich Institute, to temporarily stop vaccination - until the connections have been examined and checked in more detail.
The Ministry of Health declared this with a duty of care: “The vaccinating doctors must first be informed and the vaccinees themselves must be informed about possible side effects”.
The state is legally obliged to every citizen.
Vaccination damage without prior information could lead to legal consequences.
How did the thrombosis occur?
In all reported cases, the thromboses were triggered by an autoimmune reaction, a so-called heparin-induced thrombocytopenia (type II).
In this process, antibodies against blood platelets, the so-called thrombocytes, are formed, often by an external trigger.
These are essential for blood clotting in the body.
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In the extreme cases reported, their number in the body decreased sharply.
They are excessively consumed by the immune reaction, at the same time the existing platelets clump together, which can lead to thromboses in the meninges, in the large venous vessels in the brain, which in turn can trigger a stroke.
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Otherwise, how often does thrombocytopenia occur?
The basic autoimmune reaction to one's own blood platelets can occur especially during medical treatments with heparin.
About one to five percent of these patients develop them, with one third developing thrombosis in the body.
When heparin is administered, the side effect occurs much more frequently than previously known cases after vaccinations.
It is often a result of viral diseases and can be treated.
The dreaded sinus vein thrombosis, on the other hand, occurs very rarely each year with a frequency of three to four per million adults; women are affected in 75 percent of cases.
A study from the Netherlands, however, assumes a significantly higher frequency, around 13 cases per million people.
It is believed that the cause of the gender difference is that taking the pill may favor the occurrence.
In terms of age, it is mainly younger people around 30 who are affected, and in many cases tumors or injuries such as a traumatic brain injury are also the cause.
Have there been similar cases with other Covid vaccines?
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Yes.
In fact, several dozen similar cases occurred in the US as early as January after vaccination with the Moderna and Pfizer / Biontech vaccines.
There was also at least one death, the doctor Dr.
Gregory Michael from Florida.
The cases were recorded in the government's Vaccine Adverse Event Reporting System.
The New York Times reported on this at the beginning of February, and a scientific study also appeared in the American Journal of Hematology.
Symptoms appeared between one and 23 days after vaccination.
Several people have had thrombocytopenia in the past or had low platelet counts in their blood beforehand.
The best treatment was a combination of platelet transfusions, corticosteroids, and immunoglobulins.
Thrombocytopenia is also a known side effect of vaccinations against mumps / measles / rubella - the prevalence here is 1: 40,000; it also occurs in rare cases with vaccination against chickenpox.
The severity of the platelet loss determines how serious it can end, especially if brain thrombosis occurs.
Can thrombocytopenia also occur with Covid 19 disease?
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Yes.
A study on Covid-19 patients in Wuhan, China, described the increased incidence of thrombocytopenia in patients with severe courses of the disease as early as April 2020.
The lower the number of platelets present, the higher the patient's likelihood of dying.
What are the symptoms of thrombocytopenia?
Affected people in the USA had visible, extensive bleeding in the skin, excessive nosebleeds, bleeding gums or profuse vaginal bleeding.
Jens Spahn named in his press conference on Monday as signs "strong, persistent headache and punctiform skin bleeding".
According to the Paul Ehrlich Institute, "People who have received the Covid 19 vaccine AstraZeneca and feel increasingly unwell more than four days after the vaccination - for example with severe and persistent headaches or punctiform skin bleeding - should seek medical treatment immediately ".
Isn't the pill much more dangerous?
In fact, thrombosis is much more common with the pill.
The General Secretary of the German Society for Immunology, Carsten Watzl, drew this comparison - until he stopped on Monday evening, as he explained on "Deutschlandfunk".
With regard to normal thromboses, the comparison is not wrong.
However, the vaccination stop is now about a special form of thrombosis, triggered by an autoimmune reaction.
SPD health politician Karl Lauterbach also said that the thromboses that occur after taking the pill are not comparable in severity to the thromboses that have now occurred.
But those did occur much less often.
Figures from the EMA estimate that 1,100 cases of thrombosis occur annually in one million women due to the pill - while with the AstraZeneca vaccination there were now seven particularly severe cases in one week.
The Ministry of Health added on Tuesday: “Every woman who receives a prescription for an anti-baby pill must be informed about the risk by the prescribing doctor.
For the AstraZeneca Covid 19 vaccination, the rare side effect of a sinus vein thrombosis, which can sometimes be fatal, has not yet been listed in the patient information sheet, and the state-recommended vaccination of healthy people differs from the prescription of a drug under drug law.
Trust and transparency are always important when prescribing drugs, but especially when it comes to vaccinations because they are widely used in healthy people. "
Is the possible side effect a reason not to get vaccinated?
That depends on the individual risk assessment.
Various drugs that exist on the market can in rare to very rare cases have serious side effects.
Painkillers such as ibuprofen and diclofenac alone can lead to gastric bleeding and heart attacks and strokes in two to nine cases per 1,000 patients.
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The very effective Novamin used for colic can trigger severe anaphylactic reactions.
The side effects of the pill, which is widely used as a contraceptive, are even more extensive.
In the case of vaccinations, it can be compared with the package leaflet for medication.
Anyone who does not take medication due to possible side effects that are listed as "very rare" could now shy away from vaccination.
Anyone who takes the remedy anyway should not be afraid of the vaccination.
What are the consequences of the vaccination freeze?
First of all, the entire vaccination campaign is falling behind, especially if the cases that have occurred with the Moderna and BioNtech vaccines are more heavily targeted and a vaccination ban may also be imposed here.
In the best case, however, researchers identify possible triggers of thrombocytopenia in the vaccines, vary them if necessary or not recommend it to specific people with certain predispositions.
For this, however, the relationships must be researched more closely.
How are other countries dealing with the cause?
Italy, France and Spain also suspended AstraZeneca vaccinations on Monday.
However, France was "caught off guard" by the German decision, as FranceInfo and Politico report, citing sources in the government.
They actually agreed with the federal government to wait for the EMA to be assessed, but after Germany pushed ahead yesterday, they had to follow suit.
"We adapt to the (German) line for reasons of European coherence, not because of real doubts (about the vaccine)", a ministerial advisor is quoted as saying.
Italy then followed suit for similar reasons.
“We came to a suspension because several European countries, including Germany and France, preferred to suspend vaccinations [...] in order to hold them back to carry out controls.
The choice is political, ”said Nicola Magrini, Director General of the Italian Medicines Agency, in“ La Repubblica ”.
What about those who have already received a first dose?
The Federal Ministry of Health writes: “Even with a first vaccination, you are well protected against a severe course of an infection.
There is no danger if you skip the second vaccination.
If the vaccine remains approved, you should definitely have the second vaccination.
It strengthens the protection many times over ”.