Responds to municipalities throwing “extra doses” from the vaccine bottles

Last week, the National Institute of Public Health (NIPH) updated its vaccine guide, which has had consequences in several municipalities. In the past, several of them have taken seven doses from a single vial of Pfizer’s vaccine.

– From the end of last week decided that we only draw up six doses from each glass, says municipal chief physician Inger Hilde Trandem in Tromsø municipality about the change.

During a press conference on Tuesday, the chief physician in Bodø, Tor Claudi, also stated that they are also changing their practice:

– There has been a lot of ambiguity on this. We have managed to draw up between six and seven doses so far. Now the message is to pick out six. We must deal with that, he said then.

– Special situation

Withdrawal of more than six doses is now defined by FHI as “off label”, and the extra doses must be approved by the responsible doctor, who will also be responsible for the consequences of use.

Taking the extra responsibility is unproblematic, says Levanger chief physician Tommy Aune Rehn. They are still aiming for 6.8 doses per glass of the Pfizer vaccine.

– This is about the situation we are in. It is about getting out of a special situation as quickly as we have probably not had since the Spanish flu, with a possible exception of the Asian disease. This does not happen every decade or every 50 years, he says.

He emphasizes that off-label use of vaccines is also not an abnormal practice.

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– So this is unproblematic. I find it easier to take that dose than not to take that dose, he says.

To Trønder-Avisa, he has previously stated that it is unethical not to use the entire glass. Rehn says that it is important to do what you can to get out of the disability, and that you also have an international responsibility.

– We have x number of vaccines in the world, and it is only the supply that says something if we get vaccinated the world and Norway. If we squander x number of doses, it is at the expense of some. What we use or throw away is not allowed to be used by others, and others may be hit harder than us, he says.

According to Trandem in Tromsø municipality, it is difficult to estimate how many doses they will miss as a result of the new practice, as there is not enough vaccine in some glasses to take out seven doses.

She does not want to go as far as her colleague in Levanger, and describes not using the seventh dose as unethical.

– But we will also use as many doses as possible. We need to see how we can do that. Before that, we must clarify some of the legal and regulatory issues around this, she says.

Researcher assures

Gunnveig Grødeland, who is a senior researcher at the Department of Immunology and Transfusion Medicine at the University of Oslo, believes the reason for FHI’s advice to use six doses instead of seven is primarily a result of the vaccine manufacturers raising the question of whether to pay per dose or per glass. used.

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– Now there are more who throw the seventh dose because they want to relate to what FHI recommends. What do you think about it?

SHOULD BE AS GOOD: – There is no reason to believe that any difference in dose number seven, six, five, number one and so on. So it goes just fine, says researcher Gunnveig Grødeland. Photo: Rune Blekken

– It again depends on what agreement you have with the vaccine manufacturers. That said, we are in a situation where there is actually a shortage of vaccines and then I think in principle that you should use what you actually have available, says Grødeland.

She says that there is also no reason to believe that the seventh dose is less safe or effective than the other doses in the vial.

What is in the vaccine vial is the same whether it is the seventh dose or the first, but it obviously requires that the vial is treated in accordance with all the guidelines from the first to the last dose, she says.

– There is no reason to believe that there is any difference in dose number seven, six, five, number one and so on. So it goes just fine, Grødeland continues.

Does not change practice

Municipal chief physician John David Johansen in Drammen municipality tells TV 2 that they got to take out seven doses initially, but that they mainly now only get to take out six.

Infection control doctor in Stavanger, Ruth L. Midtgarden, tells TV 2 that they encourage everyone who vaccinates to take out six doses of each vial, and that it is up to the doctor to decide whether to take out a seventh, if it is possible.

– We use the procedure that FHI recommends for withdrawal of six doses, and therefore do not plan for seven doses. If there seems to be a sufficient seventh dose, it is okay to use it if one can plan for dose two for the person receiving it. This happens occasionally, she says.

Oslo Municipality also continues to use the opportunity to collect a seventh dose still.

– The chief infection control officer in Oslo has decided that if you can easily get an extra, full dose from the vial, the dose can be used. This is implemented in our routines, writes communications consultant at the Health Service in Oslo, Kjartan Sverdrup, in an e-mail to TV 2.

He adds that they do not have an overview of how often an extra dose is taken out.

Refers to the Norwegian Medicines Agency

FHI chief physician Preben Aavitsland told VG about the change:

– We do not want to recommend a use that is outside what is approved by the Norwegian Medicines Agency. The person responsible for the municipality’s vaccination can approve off-label use.

On Tuesday, FHI referred to the Norwegian Medicines Agency for questions about the vaccine dose topic. To TV 2, medical director there, Steinar Madsen, says that this is about formalities.

– This vaccine is approved for six doses throughout Europe, and we must stand behind it, as one of the drug authorities in Europe.

At the same time, he emphasizes that off-label use is permitted in Norway.

– But then you take on a certain responsibility. There are lots of drugs that are used off-label in Norway, and every single time it is the doctor who takes responsibility for this.

He says that Tromsø and Levanger have landed on different solutions:

– I think this made a lot of sense. One has landed on one, and will move on, while the other has landed on the other, says Madsen.

He says that it is more difficult to withdraw the seventh dose, but that it does not involve a greater risk, if it is taken correctly.

– It must be 0.3 milliliters.

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