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Covid-19 vaccinations for children under the age of twelve have so far only been carried out "off-label" in Germany
Photo: bogdankosanovic / Getty Images
An advisory panel to the US FDA has recommended that the Biontech / Pfizer vaccine be given emergency approval to five to eleven year olds.
Although the recommendation is not binding on the final decision, the FDA usually follows the experts.
The FDA's final decision could be made within hours or days of the advisors' recommendation.
The CDC health authority then has to deal with it formally.
According to the White House, a vaccination campaign for the approximately 28 million affected children in the USA could start as early as November.
The government will deliver 15 million doses of vaccine to paediatricians, clinics and pharmacies within a few days of approval, it said.
Biontech and Pfizer have also applied for approval of their corona vaccine for children of this age group in Europe, as they announced in mid-October.
Accordingly, they transmitted the relevant data to the EU Medicines Agency Ema.
According to Biontech / Pfizer, a clinical study showed that the vaccine was "well tolerated" for children of this age group and produced a "strong immune response" one month after the second dose.
Compared to adults and adolescents, the five to eleven year olds were given a significantly lower dose of the vaccine.
They received the second vaccination after 21 days.
2268 children of the age group took part in the study.
Stiko wants to carry out its own data analysis
For Germany, the question of evaluating the vaccine for children is still open, said the chairman of the Standing Vaccination Commission (Stiko), Thomas Mertens, of the German press agency.
"We do not yet have a database for our assessment and recommendation." First of all, approval by Ema is important, the time is still open.
It is clear, however, that such a study with fewer than 3,000 test subjects could not record the risk of rare side effects.
The same problem arises for the panel as before the vaccination recommendation for 12 to 17 year olds, said Mertens.
»Children have a very low burden of disease from Sars-CoV-2.
It is therefore important to carefully weigh the expected positive effects and possible adverse effects from the vaccination against each other. «Stiko will again carry out its own data analysis.
For Mertens, the starting position in the USA is not comparable to that here.
»Children there are clearly more likely to be seriously ill with Covid-19.
This may be due to the health system there and the higher proportion of children with risk factors such as metabolic syndrome or poorly controlled diabetes. "
The vaccination in the age group of 12 to 17 year olds was originally recommended by Stiko primarily for children and adolescents with certain risk factors for severe disease.
These include, for example, being very overweight or chronic lung diseases.
The general vaccination recommendation only followed later, in mid-August.
The federal and state health ministers had already agreed on broader vaccination offers for children from the age of twelve.
Could this be repeated with the younger children - first a vaccination offer from politicians and later the green light from Stiko?
"We hope that doesn't happen," said Stiko member Martin Terhardt.
"This is the only way to prevent renewed uncertainty and mistrust." Vaccinations in this age group require careful and well-coordinated preparation with good data and reliable statements for both parents and doctors.
Approval in Europe in one month at the earliest
For the professional association of paediatricians, spokesman Jakob Maske does not expect EMA approval until mid-November at the earliest. "We will then wait for the Stiko recommendation." As with the 12 to 17-year-olds, he initially counts on a recommendation for chronically ill children and possibly with an "optional rule" that also enables vaccinations for all other children. "The difficulty is that so far there is a lack of experience from other countries."
When it comes to the question of the need for vaccination, according to the Berlin pediatrician, it is also important to consider that the highest proportion of so-called pims cases is observed in five to eleven year olds: the "Pediatric Inflammatory Multisystem Syndrome (Pims)", in which it If severe inflammatory reactions occur in various organs, this rarely occurs as a result of the corona infection, but it requires hospital treatment.
Sars-CoV-2 is currently detected in Germany in particular in children and adolescents.
The seven-day incidence in five to 14-year-olds was given by the Robert Koch Institute on Monday as 203, and the trend is rising.
The spokesman for pediatricians, Maske, reported that there was a lot of pressure from some of the parents who wanted to have their children vaccinated as soon as possible.
There are doctors who specifically offer vaccinations in so-called "off-label use", that is, even without approval for the age group.
This is not illegal, but ultimately a question of security, said Maske.
Overall, however, he assumes that the number of people vaccinated this way is very low.
It is to be hoped for the success of the vaccination campaign with children that politicians do not again put public pressure on the Stiko, said Maske.
"This caused a lot of confusion among 12 to 17-year-olds and cost us paediatricians a lot of persuasion."
kry / dpa
