On December 13th, a week earlier than originally announced, the first of a total of 2.4 million doses of Comirnaty children's vaccine from Biontech / Pfizer are to be delivered in Germany. For some doctors and parents it is too late. The increased health risk of one's own child due to a previous illness (lung or heart disease, Down syndrome and others) and the currently above-average number of cases in the age group of five to eleven year old children as well as the associated risk of infection in schools has already turned some into a medical one Tricky trick: you vaccinate the children “off-label”. In principle, this is a "non-intended use". This is by no means forbidden in medical practice, but completely legal,especially since the official approval of the adult vaccine itself by the European approval authority EMA was extended first to the over eleven year olds and last on 25 November to the 5 to 11 year olds.
Joachim Müller-Jung
Editor in the features section, responsible for the “Nature and Science” section.
Follow I follow
Are the adult and children's vaccines made up in the same way?
Basically, the children's version of the Biontech / Pfizer vaccine is the same active ingredient with the same additional ingredients - albeit in different concentrations - as the Comirnaty vaccine, which has been approved for almost a year and has been inoculated billions of times. Therefore, it is only an extension of the EMA approval and not a much more complex new approval. Initially, the active ingredient was delivered undiluted for reasons of better storage, the liquid in the vials was increased with a saline solution before the vaccination and the active ingredient was diluted accordingly. In the meantime, the vaccines are delivered ready-to-use and therefore also diluted. The vials with the adult version can be recognized by a gray lid,the one with the children's version on an orange lid.
Is it problematic to take the children's vaccination doses from the adult bottles that are already available?
It is crucial that the child vaccination is approved with a third dose of the adult and youth vaccination and is also administered in this way, i.e. 10 micrograms of concentrate per injection instead of 30 micrograms of the active ingredient. A ready-to-use vial of the diluted adult vaccine can be standardly withdrawn six doses of the vaccine. The 0.3 milliliter of liquid contains 30 micrograms of the vaccine. If you want to vaccinate children with the vaccine from an adult bottle, you can theoretically receive 18 doses of 10 micrograms each. However, only a maximum of 0.1 milliliters may then be drawn into the syringe. This is a small amount that can only be dosed precisely with special fine-dose syringes. In the children's vaccine, which is available from 13.December is to be delivered ready for use, the 10 micrograms for each dose are in 0.2 milliliters - i.e. in twice as much liquid. This makes dosing just before vaccination safer.
Do the doctors take special liability risks?
In principle, doctors are permitted to use drugs that are not approved for use. As long as the specially prepared, registered children's bottles are not yet officially available, the use of the differently dosed adult bottles for children under eleven is considered to be off-label. In off-label use, all drug applications within the approval are usually also covered by liability law. Doctors do not necessarily have to wait for the recommendation by the Standing Vaccination Commission (STIKO); their opinion does not affect approval. However, many medical professionals trust the judgment of the STIKO,because experience has shown that this voluntary recommendation committee within the Robert Koch Institute evaluates and weighs up the scientific evidence on safety and effectiveness particularly carefully. It is expected that the STIKO will make its recommendation for child vaccination before December 13th and - according to unofficial statements by STIKO members - first of all to make a recommendation for children with previous illnesses, similar to the youth vaccination.