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Precious vaccine doses are being thrown in the bin in Germany because of the limitations on the number of vaccination units approved by the European Medicines Agency (EMA) per container. With the vaccine, a so-called excess amount is supplied per vial or ampoule. If it is used, it goes beyond the number of vaccination units approved by the EMA.
Research by NDR Info shows that doctors in the north of Germany deal differently with this unclear legal situation.
And many vaccine doses apparently end up in the bin instead of in an arm.
In her surgery in Hamburg-Altona, doctor Jana Husemann also vaccinates the often additional and not officially approved eleventh dose per ampoule of AstraZeneca, with the Biontech vaccine it is the often additional, but not officially approved, seventh dose.
The coronavirus pandemic is at a critical point, says the doctor.
It was now a matter of speed so that many people can be vaccinated quickly.
In addition, there is a shortage of vaccines, “and then it is really irresponsible not to exhaust everything that is currently possible”.
Germany: Doctors reveal vaccine vials are being thrown in the bin
Coronavirus vaccine doses administered in the world as of April 28
Jana Husemann is the chairwoman of the Hamburg General Practitioner Association and would like the city to make a clear statement on the subject.
Many of her colleagues do the same, but still way too many doses of the vaccines are unnecessarily thrown away, she says – out of fear of being held liable for any vaccine damage that might result.
She said: “It would be nice if there were also an official announcement that you simply have a bit of backing to use the seventh dose.”
She herself was doing this without an official announcement, and so do many of your colleagues, in her estimation.
In the Hamburg vaccination centre in the exhibition halls, on the other hand, only the permitted number of vaccination doses is used, the rest is thrown away.
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The day before, 8,268 people were vaccinated here, which is shown on a screen above the entrance. For these 8,268 vaccine doses, excess vaccine had to be thrown away, as Dirk Heinrich, the medical director of the vaccination centre, says.
It was a matter of responsibility, Dr Husemann said.
She explained: “Doctors who give vaccinations are responsible for the exact vaccine that is being used. And we cannot guarantee that here. That is not possible. That is why you cannot get a seventh or an eleventh dose here at the vaccination centre.”
In a doctor’s surgery, however, this is possible.
She continued: “If the family doctor wants to do that, then she can do it. But she is also responsible for ensuring that there is enough of the vaccine in all seven syringes, or for AstraZeneca, in all eleven syringes.”
In the vaccination centre, this is not possible for legal reasons.
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So far, almost 240,000 doses of Biontech and 91,000 doses of AstraZeneca have been inoculated in the Hamburg vaccination centre.
If one takes Jana Husemann’s calculations as a basis, one would have to assume that around 35,000 potential doses of Biontech and 8,000 potential doses of AstraZeneca have been thrown away at the vaccination centre since the vaccinations began.
Head Dirk Heinrich can understand the displeasure about this.
He said: “Yes, of course one is sorry if a vaccine cannot be used in this way.
“Personally, I believe that it is simply not feasible in large centres. Unless the state says: ‘Do it!’.”
If a federal state were to issue a corresponding instruction, it would be of help from its point of view.
At the request of NDR Info, the Hamburg health authority writes that there are no binding instructions for action and so fare none are being planned.
As long as the doses are taken in line with EMA approval, any other decision is the responsibility of the vaccination doctor.
A survey by NDR Info among the 16 state health ministries and authorities shows a confusing mixture of different announcements and ambiguities.
In Schleswig-Holstein, for example, the additional dose can be used, while in Lower Saxony physicians are even asked to do so.
However other federal states like Hamburg have made the decision the responsibility of the vaccination doctor.
In Rhineland-Palatinate the additional dose is not only recommended, but the state even explicitly assumes liability for it.
A letter from the Federal Ministry of Health to the state ministries says that using the additional vaccine doses is possible and legally permissible under certain conditions.
But Mr Heinrich says that is not enough for the head of the Hamburg vaccination centre.
The responsibility for safe removal remains with the doctor.
Dr Husemann drew different conclusions from the letter from the Federal Ministry of Health.
She said: “It’s like this: We mustn’t act with gross negligence. Of course, we have to be careful with every vaccination, and of course that is also the case with this vaccination.
“But the liability, the risk does not increase because you take out seven and not six.”
Additional reporting by Monika Pallenberg