I.n the bottles of the vaccine manufacturer Biontech literally have more potential than is often used. If it were used up, tens of thousands more people could be protected against Covid-19 every week from the same number of vials. The chairman of the Hamburg Association of Statutory Health Insurance Physicians, Walter Plassmann, estimates that seven instead of six cans could be obtained from every third bottle. Calculated in this way, not only 3.44 million Biontech vaccinations would be possible in the vaccination centers and general practitioners’ practices for the coming week, but 191,000 more.
However, the administration of the extra dose is in a gray area. The Paul Ehrlich Institute announced that the additional extraction is neither intended nor permitted. A spokeswoman recalled that the European Medicines Agency (EMA) only approved the use of 6 instead of 5 doses per bottle in January. This can only be done with special vaccination equipment. A Biontech spokeswoman confirmed that the filling height of the bottles is always the same. How many doses can ultimately be removed depends on the combination of syringes and cannulas used, which must have the lowest possible “dead volume”. This is a cavity that does not empty when inoculated; the vaccine remains unused in the cannula.
Legal certainty is crucial for doctors
The company spokeswoman made it clear that Biontech is currently not planning to apply for approval to be extended to seven doses. Plassmann, however, advocates it. It would not be “regular”, i.e. always possible, to win a seventh dose, but the EMA approval could say “up to 7 doses”. The state of Baden-Württemberg is also in favor of it: “In principle, we would welcome EMA approval for the seventh dose,” says a spokesman for the Ministry of Health. However, the approval should “of course not lead to the seventh dose being counted as full and consequently the manufacturers delivering less.”
This is exactly where observers see a danger, and it probably also explains why the Federal Ministry of Health is holding back with demands for an extended approval. Because the EU orders and pays for the cans, not the bottles. “In the worst case, Germany will even get less vaccine when the approval of the seventh collection comes,” says the medical director of a large vaccination center. From Baden-Württemberg it is therefore said that as long as there is no EMA approval, a “pragmatic approach” should be demonstrated by inoculating the seventh dose whenever possible.
Most of the other federal states indicate that they adhere to the six units. Raising the seventh is the responsibility of the doctor. Under no circumstances should the liquids from different bottles be mixed. In case of doubt, the leftovers are discarded; how much that is nobody knows. North Rhine-Westphalia has regulated in a decree that there are no concerns about the seventh dose if it comes about in full. Rhineland-Palatinate goes even further. Against the background of the shortage, the Ministry of Health explicitly “recommends” the seventh dose, provided that this is possible without compromising. “This creates the necessary legal security for the doctors,” says a spokeswoman for the ministry in Mainz.
This legal certainty is crucial for doctors. Plassmann from Hamburger KV warns that the administration can only take place “off label”, i.e. outside the permitted framework. That is possible, but then the doctor is liable. At least the doctors would have to make sure that the vaccinated with the seventh dose were informed of this and that they agreed in writing. “Otherwise it can get tricky.”
According to his spokesman, Health Minister Jens Spahn is “in favor of the seventh dose being drawn from the vial. But that is not always technically feasible. ”Regarding the legal question, the spokesman says that the objection of the doctors that they would then assume liability is not correct. Even now, regardless of the number of doses, the following applies: “The safe removal of all vaccine doses from a multi-dose container is fundamentally the responsibility of the doctor or the staff who draw the vaccine into suitable syringes under professional responsibility.”
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