The nocebo may cause blood clots
Thrombosis cases after Astrazeneca vaccination: vaccination stop is controversial
Tuesday March 16, 2021
Berlin - Six sinus vein thromboses and a cerebral hemorrhage in connection with the vaccination have brought the COVID-19 vaccination machinery to a standstill in the middle of the inflammatory infection process. But is it really appropriate to stop vaccination with the Astrazeneca vaccine?
The European Medicines Agency (EMA) remains "deeply convinced that the benefits of the Astrazeneca vaccine outweigh the risk," as the agency's chief Emer Cooke pointed out at a video press conference today, and there is currently no evidence that the Astrazeneca vaccine caused blood clots in individual vaccinated individuals, Cooke emphasized.
The EMA chief said it was "not an unexpected situation" when rare events came to light while vaccinating millions of people. "It is now our task to investigate whether the cases are real side effects or accidental coincidences." The definition of a "case" is also of great importance. The EMA is expected to announce the results of its “rigorous analysis of all available data and the clinical circumstances of the events” the afternoon of the day after tomorrow.
PEI: connection with vaccination "not implausible"
The special cerebral affections that led to the suspension of vaccinations with the Astrazeneca vaccine would have affected people between the ages of 20 and 50, as the Paul Ehrlich Institute (PEI) announced today.
Six of them had a so-called sinus vein thrombosis, all women of younger to middle age. Another case of cerebral haemorrhage due to a lack of platelets was medically very comparable.
"All cases occurred between four and 16 days after being vaccinated with Astrazeneca's COVID-19 vaccine," it said. Three of the seven people affected died.
All the experts consulted for the assessment were unanimously of the opinion that a pattern can be seen here and that a connection between the reported diseases and the Astrazeneca vaccination is "not implausible", the PEI continues. The number of cases after such a vaccination is therefore statistically significantly higher than the number of cerebral vein thromboses that normally occur in the population without vaccination: "About one case would have been expected, seven cases had been reported."
Therefore, the PEI already recommended yesterday that vaccination with the COVID-19 vaccine from Astrazeneca in Germany be suspended as a precaution in order to further analyze the cases.
"More people will die if vaccination stops"
But there are also experts who have doubts about this recommendation: For the Medical Director of the Berlin Center for Travel and Tropical Medicine (BCRT) and scientific director of the Center for Travel Medicine (CRM), Tomas Jelinek, the current stop is for further vaccination of the Astrazeneca vaccine against SARS-CoV-2 clearly not a good decision. "This is not covered by the scientific data," said the infection expert.
"On the contrary, it can be assumed that more people will die from it if the vaccination is stopped in view of the increasing number of infections and as a result fewer people will be protected from COVID-19," Jelinek predicts in an interview with the German Medical Journal.
He refers to the incidence of sinus vein thrombosis in the normal population, which is by no means exceeded by the incidences now observed after vaccination (see box).
“Unfortunately, a lot is being mixed up at the moment. Some speak of thrombosis in general, others specifically of sinus thrombosis. These are different clinical pictures and they are associated with very different frequencies, ”explains Jelinek.
Sinus vein thrombosis
Sinus vein thrombosis is a rare form of cerebral infarction. The incidence is increased in children, younger adults, women of childbearing age and in poor countries.
A distinction is made between three types: the acute form, in which the first symptoms appear within 48 hours, the subacute form, which manifests itself in two to 30 days, and a chronic form - this is only reflected in clinical symptoms after a month.
The most common form is the subacute type, which makes up about half of all cases. 86 percent of all sinus vein thromboses affect the transversal sinus, the next most frequently affected is the superior sagittal sinus at 62 percent.
In the case of vaccinations, temporal relationships can also be proven, but this does not justify direct causalities. “If in one year we have analyzed how many deaths there have been after all the corona vaccinations, then we will find that the number has increased. However, we vaccinate vulnerable groups, so that is exactly what is to be expected, ”emphasizes the expert.
Headache too unspecific as an alarm signal
The PEI recommends people who feel increasingly unwell more than four days after the Astrazeneca vaccination - with severe and persistent headaches or punctiform skin bleeding - to seek medical treatment immediately.
In view of the still suboptimally analyzed deaths, Jelinek does not consider it useful to turn the very unspecific symptom 'headache' into a marker for sinus vein thrombosis and to ask the vaccinated to pay attention to it.
"This triggers panic, because headaches are one of the most common reactions to vaccinations, which can almost be described as normal."
For example, data on the sex of those affected, on the age and the presence of previous illnesses would be important for the assessment of the sinus vein thromboses that have occurred, as Peter Berlit, Secretary General of the German Society for Neurology (DGN), emphasizes. A causal relationship between vaccination and thrombosis has not yet been established in any case.
"The causal link is completely open here," confirms Berlit. "That's why vaccination continues in England and Canada."
The actual increase in frequency is unclear
With 1.6 million Astrazeneca people vaccinated in Germany, seven cases correspond to around four cases per million people who have been vaccinated since the start of vaccinations in early February. The experts do not agree on the frequency of sinus vein thrombosis in the normal population: some speak of an incidence of three to four cases per million, but clinical case series sometimes point to ten times this incidence. Women are affected in a ratio of 3: 1; Overall, sinus vein thrombosis accounts for 0.5 to 1 percent of all strokes, according to a neurological review.
A review of 861 studies and the evaluation of eleven of them show that taking hormonal contraceptives in particular multiplies the risk: between the ages of 15 and 50, taking the birth control pill was associated with a risk increase by more than seven times.
It should also be borne in mind that the mortality rate in men in their 40s with COVID-19 is 1,000 deaths per million infections, which is considerably higher than the risk of sinus vein thrombosis, according to Paul Hunter, professor of medicine at the Norwich School of Medicine University of East Anglia.
"Of course, this possible association needs to be carefully examined, but we also need to consider the damage that will be done if we delay vaccination campaigns now, at a time when COVID-19 is still on the rise in many European countries."
Three cases of sinus vein thrombosis have been recorded in the UK to date, out of a total of more than 11 million vaccinated doses of Astrazeneca's vaccine.
For thromboses in general, EMA analyzes had shown that there was no noticeable accumulation in the temporal connection with the vaccination. The proportion of thrombosis sufferers after an Astrazeneca vaccination therefore corresponds to the spontaneous occurrence of this disease in the normal population.
Risk of bias: PEI is considering nocebo effect with Astrazeneca vaccine
Furthermore, it is unclear to what extent the observed complications could actually be due to the vaccination and whether they actually only affect the Astrazeneca preparation and not the other vaccines. Because the PEI speaks in its safety report of a "nocebo effect" to the disadvantage of the Astrazeneca vaccine. This means that more suspected side effects have been reported for the now stopped vaccine than for the mRNA vaccines from Pfizer and Moderna.
When asked, EMA boss Cooke also confirmed that the agency was also looking at the background rates of thrombotic events in the other approved COVID-19 vaccines and “it seems as if comparable figures are being reported from all over the world”.
Evidence of a connection with the COVID-19 disease itself
In addition, it should be borne in mind that a COVID-19 disease itself is associated with an increased risk of thromboembolism in general, but also cerebral sinus vein thrombosis in particular, as far as this can currently be read from the publications.
"It is therefore speculated whether the sinus vein thromboses that occurred after a vaccination could be attributed to an undetected SARS-CoV-2 infection," says Ingolf Cascorbi, Director of the Institute for Experimental and Clinical Pharmacology at the University Medical Center Schleswig-Holstein, Campus Kiel, in conversation with the German Medical Journal.
In a letter to the editor to the British Medical Journal the rhythmologist Andreas Bollmann from the Heart Center Leipzig reports that during the COVID-19 pandemic - but before the start of vaccinations - an increasing incidence of hospitalizations due to thromboembolic events, especially pulmonary embolisms, was observed in both Germany and England.
"Interestingly, there was an association between the average SARS-CoV-2 infections in Germany 14 to 17 days before hospitalization and the increased incidence of hospitalization due to thromboembolic events," said Bollmann. Even if no causal connection has been established, it is interesting to speculate that undiscovered or recently overcome SARS-CoV-2 infections may at least partially have contributed to this observation. © mls / nec / aerzteblatt.de
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