No vaccine has yet been developed and approved for children under the age of twelve, but the good news is: at least the manufacturers BioNTech/Pfizer and Moderna are working flat out to ensure that even the youngest children can soon be protected by a prick.

When is an approved vaccine coming?

BioNTech/Pfizer as well as Moderna have probably already started months ago to conduct studies on younger children - to be precise, on children between the ages of six months and eleven years. Pfizer and BioNTech say they expect final results to be available very soon, by September. Depending on what those showed, there could already be "an emergency approval in the U.S. or a change to conditional marketing approval in the EU" quickly. However, that only applies to children ages two to 11. Reliable data for children under two years of age is not expected to be available until the end of the year. Moderna has not yet given any precise indication of when data can be expected.

Are these different vaccines or just different dosages?

These are the same mRNA vaccines that adults get; however, the dosage needs to be adjusted for the body size and immune system of younger children. And not all children are the same. That is why there are also three different divisions within this age group (six months to two years/two to under five years/five to twelve years).

Rolf Hömke of the Association of Research-Based Pharmaceutical Companies says: "The companies first calculate - on the basis of empirical values - what dose might be suitable for children in this age group. That is, what amount elicits a sufficient immune response while not causing unnecessarily severe side effects. Then this dosage and a slightly higher and a slightly lower one are tested with very few subjects. After the best dosage is determined, more subjects are vaccinated with it in further study phases." In BioNTech/Pfizer's case, U.S., Finnish, Spanish and Polish medical facilities are participating in the study.

Will children also get two doses?

Until data are available, we can't say much about that. But very likely it will happen. Almost all vaccines need to be given at least twice to work well. This has to do with the way the immune system works and its defense mechanisms.

Why does it take so much longer to find a vaccine dosage for children?

It doesn't take that much longer. It's just that people started later to include children in the studies in the first place. "Only when conclusive data on the safety and efficacy of a vaccine are available for healthy adults do you gradually start clinical trials in vulnerable groups, first in adolescents and finally in children," says Klaus Cichutek, president of the Paul Ehrlich Institute. Children are under special protection in our society and should be exposed to as little stress as possible during medical procedures. That's why you have to be very careful with clinical trials in children, which makes them more costly for companies.

In addition, volunteers are needed, i.e. parents who allow their children to be involved in the studies. Understandably, finding such volunteers is often more difficult than when adults have to decide for themselves. "In the case of the Covid vaccine in particular, there was also the fact that the U.S. Food and Drug Administration now requires more study participants than originally, which in turn can extend the duration of the study," says Hömke.

Are there pediatricians who are already vaccinating children under twelve without a license?

That is the impression when you ask around among friends and acquaintances. And Jakob Maske, a pediatrician from Berlin and press spokesman for the German Association of Pediatricians and Adolescents, also says: "We know that there are apparently a number of doctors who are already vaccinating children under twelve even now and who are unhappy that they have to do it off-label." "Off-label use" is when drugs are administered outside their approved scope of use or approved patient population.

Is the administration of off-label drugs even legal?

Yes, it is. As Maske explains, there are some medications that children are given off-label because no alternative preparations exist and the children would otherwise die. That applies to heart medications for severe heart defects, for example. However, Maske also says, "These are, of course, completely different conditions that we don't have with corona infection. Severe courses or complications are extremely rare in children."

What are the reasons against vaccination without approval?

Since the registration study at BioNTech/Pfizer has not yet been completed, Maske, a pediatrician, says nothing can yet be said about the right dose of vaccine or whether children actually build up the amount of antibodies they need for adequate protection. Klaus Cichutek of the Paul Ehrlich Institute says, "Children are not small adults." Therefore, he says, guidelines for one group cannot simply be applied to the other. For parents in the risk-benefit trade-off, the risk of young children becoming seriously ill is almost zero.

Who is liable if a serious side effect occurs after vaccination without an approved vaccine?

The doctor. Jörg Heynemann, a specialist in medical law, points out that physicians do not pass on liability to parents, even if they provide detailed information: "The risk lies with the physician - or with his or her liability insurance."

Will there still be an STIKO recommendation for the vaccination of under-twelve-year-olds this year?

Jakob Maske cannot imagine that: "It is of course more difficult to obtain data that allow clear answers, the fewer vaccinated children there are. And if the risk of contracting the disease also becomes lower and lower the younger the children are, then the question will be whether there is a recommendation at all."

Photo by Prasesh Shiwakoti (Lomash)