While in Vienna and soon also in Tyrol, under-12s are being vaccinated against Covid-19 without official approval - as an "off-label" product - the rest of Europe is waiting for the approval of the EMA. As with booster vaccination, all eyes in Germany are on the Standing Committee on Vaccination (STIKO). The top health authorities in the U.S. already recommended BioNTech/Pfizer's mRNA pediatric vaccines for children five years and older a good two weeks ago. The dose for the two scheduled injections is reduced to one-third of the adult amount. In the studies with the results of more than 2200 small subjects in several countries, more than ninety percent efficacy was found - quite similar to adults. The side effect profile is even slightly more favorable, mainly short-term pain at the vaccination site, redness and in less than one in twenty cases fever or chills occurred. Due to the small size of the study, no clear statements could be made about the risks of a rare - treatable - myocarditis identified in the youth vaccination, especially in boys.
The European authorities have already received applications for approval from BioNTech/Pfizer and the American manufacturer Moderna. A decision is expected possibly as early as next week. A vaccine for children under five has not yet been fully developed. What that means for the timing of childhood vaccination campaigns in Germany, however, is still unclear. Acting Federal Health Minister Jens Spahn (CDU) expects vaccination of the slightly more than five million children in the age group to begin "before Christmas." Negotiations are underway with other countries to supply the first two and a half million doses of pediatric vaccine from BioNTech/Pfizer.
Even before recommending vaccination for adolescents, the STIKO had indicated that it would weigh the very low risks of severe covid disease in children against the also very low risks of vaccine side effects particularly carefully and, in accordance with the local risk factors, possibly also differently than, for example, the American health authorities. Israel announced at the beginning of the week that it would now also vaccinate children from the age of five.
When weighing the benefits and risks of childhood vaccination and contrasting them with the risks of Covid 19 disease, scientists are generally more divided than they are about adult vaccination. That's because in the first three waves, only a small fraction of those under 12 - less than two percent of those who even become conspicuous by Covid 19 symptoms - were treated in the hospital, and a much smaller fraction ended up in the intensive care unit. Still, there are two Covid 19 sequelae in particular that make the case for vaccination in terms of protecting children's health: pediatric multisystem inflammatory syndrome (PIMS), which has been found to cluster in adolescents a few weeks after acute infection.
Another great unknown is long covid, i.e., the secondary disease that is often associated with shortness of breath, pain in the limbs, extreme fatigue, and neurological defects lasting weeks to months. According to the epidemiological data available worldwide, it is not yet possible to say exactly how high the risks are; at the very least, it can occur just as much in adults after they have been through covid disease. Many physicians also argue that other childhood vaccinations are by no means recommended only for fatal infections. In a critical overview study, Swiss researchers led by Petra Zimmermann of the University of Fribourg recently broke down the pros and cons - as well as the many unknowns in the weighing process. Their conclusion: vaccination of children under the age of 12 could become the "global standard," but at present, more precise weighing of the pros and cons in the individual age groups are still needed. At the same time, Chinese researchers, for example, argue that especially in the delta wave and with possibly even more aggressive virus variants, childhood vaccination could help contain the pandemic. Currently, the incidence of children in many places in Germany is more than 500.