Actually, the corona vaccinations with the preparation from Astra Zeneca should finally pick up speed – and now this. After some precautionary warnings from large clinics, among others, the state of Berlin rushed forward on Tuesday and initially started using Astra Zeneca for people under 60 years of age out. Brandenburg and North Rhine-Westphalia followed, and the city of Munich also took a break from awarding the drug.
The Standing Vaccination Commission later recommended this step for the whole of Germany for the time being. And the federal and state health ministers finally decided: People under 60 should only be able to continue to be vaccinated with it “at the discretion of a doctor and with an individual risk analysis after careful information”
There was a lot going back and forth about the product from the British-Swedish manufacturer. The vaccine has been approved – but in Germany initially only for people under 65, then older people should also be able to be vaccinated with it. Ultimately, the vaccinations were completely suspended, allowed again – and now restricted again.
But what are the reasons for this bumpy development? And what is known about the possible security risks? An overview.
What exactly is it about?
There are suspected cases of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a lack of blood platelets (thrombocytopenia). The Paul Ehrlich Institute, which collects such reports, states in its safety report “a noticeable accumulation” near the time of vaccinations with Astra Zeneca.
How many suspected cases have there been so far?
31 suspected cases of sinus vein thrombosis after vaccination with the corona vaccine from Astra Zeneca were reported to the institute by noon on Monday. Thrombocytopenia was also reported in 19 cases. The outcome was fatal in nine cases.
What do we know about these suspected cases?
With the exception of two cases, all reports concerned women aged 20 to 63 years. The two men were 36 and 57 years old. According to the Robert Koch Institute (RKI) vaccination rate monitoring system, around 2.7 million first doses and 767 second doses were vaccinated by Astra Zeneca up to and including Monday. The fact that the latter number is so low is because the recommended interval between the second vaccination is twelve weeks and the EU did not approve the vaccine until the end of January. The majority of the scheduled second vaccinations will not be due until the beginning of May.
How common is this complication?
The Paul Ehrlich Institute was reported to be about one case per 100,000 Astra Zeneca vaccinations (as of March 19); according to the latest figures from Monday, it should be about 1.15 cases per 100,000 vaccinations. That is little, but more often than would be expected, because it is even rarer in the normal population: “This very rare coagulation disorder occurred more frequently among the vaccinated than would be expected numerically due to the rarity of this coagulation disorder without vaccination.”
How do such thromboses arise?
According to Andreas Greinacher from the University Medical Center Greifswald, in rare individual cases the body’s immune response could activate the blood platelets. Other researchers also suspect that the formation of the clot could take place via a strong immune response and the resulting antibodies that attach to the blood platelets and activate them.
Is the vaccination the cause?
“At the moment it is not clear whether there is a causal relationship between the vaccination and the reports of immune thrombocytopenia,” says the PEI. So far there is no evidence that the occurrence of these coagulation disorders was caused by the vaccine. But there would be further investigations to clear this up.
How have the authorities assessed the matter so far?
For the European authority EMA, the advantages of the vaccine are significantly greater than the risks. However, it was decided to include a warning in the technical information and instructions for use for these very rare occurrences.
According to the Paul Ehrlich Institute, more suspected cases are reported after Astra Zeneca vaccinations than with the other vaccines. From this, however, “one cannot necessarily infer a higher reactogenicity of the vaccine,” reports the institute. The increased reporting rate could “also be related to the increased media attention”.
How is it in the UK, where a lot of Astra Zeneca is used?
According to the drug supervisory authority (MHRA), four cases of cerebral vein thrombosis related to Astra-Zeneca vaccinations had occurred in Great Britain by mid-March, none of which are said to have been fatal. In total, millions of people have already been vaccinated with the vaccine. Since the vaccination campaign is already well advanced, 50 to 59 year olds are currently being vaccinated. The UK had never paused vaccinations with Astra Zeneca. Given the large number of doses given and the frequency with which blood clots occur naturally, there is no need to stop, the MHRA said.
What role does the age group play?
The age recommendations for Astra Zeneca have already changed. The Standing Vaccination Commission had initially only recommended the drug for people under 65 years of age – due to a lack of study data for older people. A little later, however, this was canceled and the vaccination recommended for everyone over the age of 18. In light of the most recent cases, the committee now recommends that the remedy be used only from 60. The resolutions of the federal and state governments stipulate that vaccination for priority groups one and two can also be continued for younger people after “careful” medical advice.
How important is Astra Zeneca for vaccination progress in Germany?
Astra Zeneca plays an important role in this, also for the greater involvement of doctors’ practices, which is aimed at after Easter. Deliveries of more than 56 million cans are expected throughout 2021. The German Foundation for Patient Protection demands: “So that the vaccination campaign can finally pick up speed, those who want to be vaccinated must be given the freedom to choose the serums.” But this should not give up the ethical order in the vaccination offer, said board member Eugen Brysch. “Otherwise immobile, seriously ill and people in need of care will get under the wheels.” And the SPD health expert Karl Lauterbach calls in an interview with the SZ: “More Biontech for the younger ones and more Astra Zeneca for the older ones.”