“Due to the enormous and almost no longer manageable interest” in “off-label” vaccinations against the coronavirus, he has reached the limits of his capacity – this is stated on the website of the pediatrician Andreas Doczy, who runs a practice in Vienna. “Off-label” means: still without approval from the European Medicines Agency (EMA) and without a recommendation from the National Vaccination Committee (NIG).
How great the demand for an “off-label” vaccination is can also be seen from the data on the electronic vaccination pass: In the first week of October, 1,566 children under the age of twelve were vaccinated in Austria, 304 of them fully immunized, according to the Ministry of Health on request from ORF.at. And the numbers are increasing continuously. For comparison: by mid-September there were 674 children, 156 of whom had already been vaccinated twice.
Registrations not possible at the moment
In the last week of September alone, Doczy vaccinated 149 children under twelve. “The practice is normal in the morning and there is a full vaccination program in the afternoon,” said the pediatrician in an interview with ORF.at. He started with the “off-label” vaccinations at the end of June. In August the demand was already very high. In the meantime, parents and their children come from other federal states and even from Germany.
Due to the rush, at-risk children in Doczy’s practice have so far been vaccinated first. Then children with family members who are at increased risk. Then all the other children. The demand is now so great that he is busy with children at risk: “The appointments are booked out for the next six to eight weeks. Inquiries are placed on an evidence list, registrations are not possible at the moment. “
“Children have massively restricted themselves”
“I’m really very relieved now,” says a mother, whose ten-year-old child received the first vaccination from a doctor in Vienna at the end of September. “While everyone else can now be protected by the vaccination, the children who have so severely restricted themselves in the past year and a half fall ill. This is a contamination experiment for which I do not want to make my child available, ”the mother told ORF.at.
She thought about it for a long time and was well informed – with the result: “The vaccination is so close to approval, all the data is there.” On the other hand, far too little is known about the possible long-term consequences of Covid-19 for children .
“Vaccination gives security”
“Not enough is happening at school – there are too few protective measures. We consider the likelihood of an infection to occur as very high. The vaccination gives security ”, a father explains the decision to have his nine-year-old daughter vaccinated against the coronavirus“ off-label ”in an interview with ORF.at. “Of course we did get detailed information. The special thing about this vaccination is that the studies are freely accessible. “
The pediatrician gave them extensive advice before the vaccination. His daughter, who received the second vaccination last week, was happy about the vaccination. At the beginning of September, when his daughter received the first vaccination, it was not yet difficult. “But I know some who want their children to be vaccinated now and don’t get an appointment.”
NIG advises against “off-label” vaccination
Since there is no approval or recommendation for vaccination for under twelve year olds, the responsibility lies with vaccinating doctors and the legal representatives of the vaccinated, clarifies the Ministry of Health. The NIG also advises against vaccination for children under the age of twelve before approval or recommendation is given.
The German Standing Vaccination Commission (STIKO) is also critical of the situation: Even among twelve to 17-year-olds, the decision to vaccinate was difficult when weighing the benefits and harms. It will be even more difficult for the younger generation, according to STIKO chairman Thomas Mertens in the “Stuttgarter Nachrichten” at the end of September. In this context, he expects a “wave of political pressure”. Pressure is bad in this context: “Especially because the children are supposed to serve to compensate for the vaccination fatigue of the adults.”
Every fifth new infection affects six to 14 year olds
Every fifth coronavirus infection in the last week of September affected a child between the ages of six and 14. This is shown by the current evaluation by the Agency for Health and Food Safety (AGES). According to this, of the total of 12,668 infections, 2,530 were attributable to this age group. With a 7-day incidence of 331 cases per 100,000 inhabitants, the six- to 14-year-olds also outperformed the 15- to 24-year-olds, who had the highest incidence during the summer.
The fact that under twelve cannot be vaccinated regularly is probably one of the reasons for the increasing number of infections. Another is that pupils are consistently and completely tested by tests in school – this means that there are hardly any unreported numbers, and asymptomatic infections are also recognized. And: The protection for non-vaccinated people stands or falls with the vaccination rate of the entire population – and this is still too low in Austria at just under 65 percent.
“Two children in intensive care in September”
“If significantly more adults in Austria were to be vaccinated against the virus, we would not have to talk about the Covid 19 vaccination for children today,” said Florian Götzinger, pediatrician and pediatric infectiologist at the Ottakring Clinic in Vienna, to ORF. at. In the case of adults, almost all inpatient admissions are currently unvaccinated with Covid-19. “Unvaccinated infected people also contribute most to the spread of the virus.”
Since the beginning of September there have been two children at the Ottakring Clinic who had to be admitted to an intensive care unit, one of whom had a serious previous illness. Both children have now been released again in good health. So far, the bed capacity for children has been sufficient to “optimally care for” all patients.
Only a few children would get seriously ill with Covid-19, said Götzinger. For this, however, certain resources are required. “If the virus was allowed to spread too quickly and there were, as a result, a large number of seriously ill children in a short period of time, the hospital capacities would quickly be utilized.” In Vienna, the city has prepared for such a scenario in the event of an emergency.
“Protective shield for the children”
Because of the high degree of infection of the Delta variant, it can be assumed that many people who have not been vaccinated or recovered will be infected with SARS-CoV-2 this autumn and winter, according to Götzinger. “And of course there are children too.” The extent to which the number of infections among children will increase in the next few weeks, however, depends on many different factors.
“Adults can create a protective shield for the children through their own vaccination. The vast majority of children and adolescents are still infected outside of school. ”The child infectiologist considers the current safety measures in schools to be“ a good compromise to enable children to have a more or less normal school year while at the same time ensuring that it does not become an uncontrolled one Increase in infections is coming ”.
When does the vaccination come for children under twelve?
Götzinger considers an “off-label” vaccination to be “a very personal, joint decision of the parents, the child and the treating pediatrician”. If the child has a high risk of a severe course due to a serious underlying disease, it is “certainly sensible”. But how long do children under twelve have to wait before the regular vaccination? “As far as I know, vaccinations for over five-year-olds are expected to be approved this autumn,” says Götzinger.
Pediatrician Doczy expects EMA approval by mid-November at the latest: “After that, the National Vaccination Committee has to consult. And that’s just as well. The NIG is mostly based on the EMA. “The Ministry of Health assumes that the EMA will give the green light” by the end of the year or at the latest in the first quarter of 2022 “.
Biontech and Pfizer: “Strong immune response”
Biontech and Pfizer announced in September that, following positive study results, they would apply for approval of their Covid-19 vaccine for use in children as soon as possible. The data for approval of their Covid-19 vaccine for children between the ages of five and eleven have now been submitted to the US Food and Drug Administration. The EMA and other approval authorities worldwide are to follow soon. In the decisive study with five to eleven year olds, the vaccine was well tolerated and produced a strong immune response, the two companies said.