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Coagulation disorders after AstraZeneca vaccinations: »More coincidence than cause«

2021-03-12T12:28:42.930Z


In several countries, the AstraZeneca substance is currently not vaccinated because individual people who have been vaccinated have had health problems. But what conclusions do the data allow - and is the benefit greater than the harm?


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AstraZeneca vaccine: "No cause for concern at the moment"

Photo: Chris Jackson / Getty Images

It's the batch number ABV5300 that is causing a stir in Europe right now.

It contains one million doses of the AstraZeneca vaccine and has been shipped to 17 EU countries;

Germany is not among them.

Austria had ordered a vaccination freeze at the beginning of the week after a 49-year-old died of severe coagulation disorders and a 35-year-old suffered a pulmonary embolism.

However, it is completely unclear whether the vaccine was the cause of the blood clots or whether they happened at the same time.

The European Medicines Agency (Ema) has so far only reported 30 cases of coagulation disorders after an AstraZeneca vaccination - and that in almost five million people vaccinated so far.

That would correspond to a rate of 0.006 per 1000 people.

Inappropriate risk-benefit balance

"The number of thromboembolic incidents in vaccinated people is not higher than the number in the general population," writes the Ema in a statement.

After the first examination, there was no evidence of a causal relationship.

"The benefits of the vaccine outweigh the risks, and the vaccine can continue to be administered while the coagulation disorder review continues," said Ema's Pharmacovigilance Risk Assessment Committee (Prac), which is responsible for the assessment and safety of medicinal products for human use.

Nevertheless, numerous nations have decided - possibly prematurely - to follow Austria's example.

After there was also a death in Denmark from a coagulation disorder in connection with the AstraZeneca vaccination, it also stopped the vaccinations.

The Baltic states, Norway, Iceland, Luxembourg, Thailand and Romania also suspended the vaccinations.

However, these decisions could do more harm than good, says Mathias Pletz, director of the Institute for Infection Medicine and Hospital Hygiene at the University of Jena.

The reason: By suspending vaccinations in Denmark for two weeks initially, it is not only very likely that more people will get Covid-19 than without this decision - and about five percent of them will certainly also be severe.

Covid 19 disease also increases the risk of blood clots.

According to a US study, blood clots formed in 16 percent of Covid patients.

Pletz therefore speaks of an inadequate risk-benefit assessment.

The Paul Ehrlich Institute (PEI), which is responsible for the evaluation and approval of vaccines in Germany, joins the evaluation of the Ema.

"In Germany, a total of eleven reports of various thromboembolic events in around 1.2 million vaccinations had been reported by March 11, 2021," writes the Pei.

"Four people died." Looking at the information currently available, there is currently no indication that the vaccination caused these diseases, so the benefits outweigh the risks.

"Vaccination stop was wrong"

SPD health politician Karl Lauterbach on Twitter

"The measures taken are of course to be understood as precautionary measures," says vaccine researcher Leif-Erik Sander from the Charité in Berlin.

“It is important and right that all events are followed up very carefully.

This is also done by the responsible authorities.

But I don't see any reason to worry at the moment. "

Health Minister Jens Spahn criticized the suspension of vaccinations in Berlin on Friday: "I regret that on this basis - as of Friday morning - some countries in the European Union have suspended vaccination with AstraZeneca."

The SPD health expert Karl Lauterbach tweeted: “It is correct to investigate this further.

But the vaccination freeze was wrong.

A suspended vaccination is fatal for many who are now giving up. "

Clemens Wendtker, head physician for infectious diseases and tropical medicine at the Munich Clinic Schwabing, also believes that Ema and PEI are currently correct: “Overall, based on the current state of knowledge, it can be assumed that there is a high probability that there is no causal connection between the vaccination and the few thromboembolic events there - instead of a causality, a coincidence is to be assumed, i.e. more coincidence than cause. ”He also considers the risk of developing a Covid-19-associated thrombosis to be“ many times higher ”.

The vaccine from AstraZeneca has so far been used less frequently in Germany than that from Biontech / Pfizer.

The latest safety report from the Paul Ehrlich Institute counted 363,645 vaccinations with the AstraZeneca product by February 26.

This is compared to 5.4 million vaccinations with the preparation from Biontech / Pfizer.

Vaccinations with the preparation from Moderna are even rarer (168,189 vaccinations).

Icon: The mirror

With material from dpa and AFP

Source: spiegel

All tech articles on 2021-03-12

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