AstraZeneca: what is the difference between the Italian and German cases

AstraZeneca: what is the difference between the Italian and German cases


While awaiting the EMA verdict on the safety of AstraZeneca's anti-Covid vaccine, the German agency Pei explains the reason for the temporary suspension of the vaccination, namely an increase in a special form of cerebral venous thrombosis

(photo: pixabay) While Europe awaits the final decision on the safety of AstraZeneca's vaccine by the EMA, the agency continues the investigation, reiterating that there are so far no indications that vaccination is the cause of the serious events observed in recent days in several European countries. However, Italy has also decided to suspend the administration of this vaccine as a precaution, after the evaluation of the German agency that deals with the safety of drugs, the Paul Ehrlich Institute (Pei), according to which there would have been an increase in a special form of cerebral venous thrombosis, associated with thrombocytopenia (lack of platelets) and bleeding, temporally related to the AstraZeneca vaccine. An assessment that prompted Germany to suspend administration of the vaccine.

But what is the difference between the cases observed in Germany and those recorded in our country? Let's start with the German ones. As reported by the Pei, out of over 1.6 million vaccinations carried out in Germany to date, there have been 7 cases (6 women and one man), of which 3 fatal, of cerebral venous thrombosis recorded after the administration of the vaccine. "Despite the high number of vaccinations with AstraZeneca, it is above average", reads the German agency's Faq. "For this reason, the Pei has decided to recommend a temporary suspension of vaccinations".

Cerebral venous thrombosis, we recall, is a very rare form of thrombosis (the incidence is estimated between 2 and 5 cases per million per year), characterized by occlusion of the cerebral vein through blood clots . The normal rate, continues the German agency, should be statistically expected in the vaccinated group and within a period of 14 days from administration, from 1 to 1.4 sinus vein thrombosis, again out of 1.6 million vaccinations. “According to this calculation, more cases of sinus thrombosis have been reported than would be statistically expected,” they write from the Pei. "Anyone who develops persistent headache from 4 to 14 days after vaccination with AstraZeneca or develops pinpoint skin bleeding should contact a doctor."

Since thrombosis events can also occur with contraceptive pills, why all this chaos about the AstraZeneca vaccine? As the Pei points out, thrombosis, even fatal, is known to be a very rare side effect of birth control pills and are in fact listed in the package insert. "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," it reads. "Trust and transparency are always essential when prescribing drugs, but especially when it comes to vaccines, which are widely used in healthy people."

In Italy, thromboembolic events in temporal relation to vaccination recorded so far (up to 10 March, according to the EMA, a total of 30 cases of thrombotic events were recorded on 5 million vaccinated, but the data are evolving ), only one could be cerebral venous thrombosis (but is still being investigated to confirm this). As of February 26, according to the latest report on the surveillance of AIFA vaccines, 40 reports with a death outcome have been entered, for a reporting rate of approximately 0.97 out of 100 thousand doses administered. "There are no cases of death as a result of anaphylactic shock or major allergic reactions," the document reads. "Very often death is linked to cardiovascular causes in patients who had underlying cardiovascular diseases".

The Italian Association of Epidemiology has also recently talked about it, which in a recent note underlines how, based on the data of the scientific literature relating to the incidence of deep vein thrombosis and data on hospitalizations, it is possible to estimate that every year in the general population (between 35 and 70 years of age) about 80 cases per 100 thousand people are expected. This estimate, the experts add, leads to a number of cases expected per week of 1.5-2, or 6-8 cases in the last month per 100 thousand people.

"As of March 14, 2021, it appears that 184,219 subjects belonging to the Armed and Police Forces and 610,305 subjects belonging to school staff received the AstraZeneca vaccine, within a month, for a total of almost 800,000 people ”, comment the experts. “In the light of the available evidence, therefore, in this population, a number of hospital admissions for TB between 48 and 64 should have occurred in one month for the effect of chance alone (6-8 cases / 100,000 per 800,000 people). These cases certainly occur not as a result of the vaccine but as a result of the normal incidence of the disease ".

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