Berlin (dpa) – The seven cases of brain diseases that caused the Astrazeneca vaccinations to be suspended affected people between about 20 and 50 years old. The Paul Ehrlich Institute (PEI) announced this on Tuesday.
Six of them had a so-called sinus vein thrombosis, all of them young to middle-aged women. Another case of cerebral hemorrhage due to platelet deficiency in a man was medically very similar. “All cases occurred between 4 and 16 days after vaccination with the Covid-19 vaccine Astrazeneca,” he said. Three of the seven people affected died.
All experts consulted for the review were unanimous in the view that a pattern can be seen here and that a link between the reported diseases and the Astrazeneca vaccination is “not unlikely,” the PEI said. Whether there is actually a causal relationship is currently being investigated.
The rate of cases following Astrazeneca vaccination is therefore statistically significantly higher than the rate of cerebral venous thrombosis normally occurring in the non-vaccinated population: “About one case would have been expected, seven cases were reported.”
The severe cerebral venous thrombosis with platelet deficiency does not affect the age group at high risk of a serious or fatal course of Covid-19. Not seniors are affected, but people from younger to middle age.
“After considering the above facts in their entirety, the Paul Ehrlich Institute recommended that vaccination with the Covid 19 vaccine AstraZeneca in Germany be suspended as a precaution in order to further analyze the cases,” the institute concluded.
The assessment of whether the vaccine can be used, although it may cause this very rare side effect, is made at European level by the European Medicines Agency (EMA) and at national level by politicians. Experts from the EMA will therefore this week investigate whether and how the findings affect the benefit-risk profile of the Astrazeneca vaccine and the EU approval of the vaccine. A first result can be expected this week.
It should be understood that seven out of a total of 1.6 million people vaccinated are a very rare possible side effect. Thrombosis is also known to be a very rare side effect of the contraceptive pill. The point with this comparison is that this side effect of the prescription pill is explicitly stated in the patient information. Every woman should be informed of this risk by the prescribing physician. However, in the case of the vaccine, sinus venous thrombosis with associated platelet deficiency has not yet been reported in the patient information.
According to the PEI, the seven registered affected individuals continued to feel unwell for days after the vaccination and had more headaches. People who feel consistently unwell more than four days after the Astrazeneca vaccination – with severe and persistent headaches or punctiform skin bleeding – should seek immediate medical attention, the PEI advised.
The institute considers it premature to discuss a mix of vaccines with Astrazeneca if a second vaccination has not yet taken place. It remains to be seen whether vaccination with the Astrazeneca vaccine will be permanently discontinued. There are also no data available on a combination of different vaccines. “For these reasons, vaccination protection should not be supplemented with any other vaccine at this time.”
In sinus venous thrombosis, certain veins in the brain are blocked by blood clots. The main symptom is a headache. In addition, sick people can develop seizures, paralysis or speech disorders. Platelet deficiency, in turn, leads to an increased bleeding tendency. Symptoms include point bleeding in the skin or mucous membranes and sometimes heavy nose bleeds.