Enlarge image
In a vaccination center, children accidentally received the wrong vaccine (symbol image)
Photo: Christian Charisius / dpa
The vaccinations for children between the ages of five and eleven are currently causing a stir among many parents.
Some prefer to have their children vaccinated sooner rather than later in order to save them further quarantines and the risk of corona infection.
Others worry that the little ones are not taking the vaccine well.
The news about a breakdown from the vaccination center in Attendorn, North Rhine-Westphalia, contributed to the uncertainty earlier this week. According to the North Rhine-Westphalian Ministry of Health, three children - seven, ten and eleven years old - were accidentally vaccinated with the booster vaccine from Moderna. For children of this age group, however, only the children's vaccine from Biontech is currently approved. The parents of two of the children affected reported the incident on Sunday.
The report probably caused a stir because it was initially unclear how many children were involved.
As the »Siegener Zeitung« reports, the serial number 249 is said to have been on the message with which the Olpe district informed the public.
Apparently, some authors therefore mistakenly thought that there were more than 200 affected children.
Meanwhile, emotions are boiling up on social media, there is talk of child welfare.
How bad is the mix-up from a medical point of view?
And how do vaccination centers ensure that such an error no longer occurs?
The overview.
What happened?
Last Sunday in the Attendorn vaccination center in the Olpe district in the southern Sauerland region, three children under the age of 12 were accidentally vaccinated with the booster vaccine from Moderna, although only the children's vaccine from Biontech is approved for this age group.
The North Rhine-Westphalian Ministry of Health confirmed the incident to SPIEGEL.
The district of Olpe had already informed about the mix-up on Sunday.
The mistake was noticed by the vaccinating medical assistant, it said.
The parents of the children concerned were immediately informed of the incident.
According to the »Siegener Zeitung«, however, the parents noticed the incorrect vaccination based on the entry in the vaccination card.
According to the information, no abnormalities were found in the children at the time they left the vaccination center.
The Ministry of Health also had no information that any of the children had side effects.
They are fine.
The parents of two of the children affected then reported the incident to the police, a spokesman for the Attendorn police station confirmed to SPIEGEL.
It is now being investigated because of bodily harm, the case had been sent to the Olpe criminal police.
"In the investigation, it must be checked whether there are indications of criminal behavior by people working in the vaccination center of the Olpe district in connection with the vaccinations of the children," said the NRW Ministry of Health.
After an exchange among all relevant stakeholders on Monday, including the medical and organizational head of the vaccination center, District Administrator Theo Melcher (CDU) announced that the vaccine specialist and an affected family with two children noticed the mistake.
It can be assumed from an individual failure, the specialist was immediately removed from the vaccination process.
How bad is it when children under the age of 12 are vaccinated with Moderna instead of Biontech?
This question can be answered from two different perspectives: from a medical and a legal point of view.
From a
medical perspective
, the oversight isn't as bad as it sounds.
The third vaccination from Moderna contains only half the dosage - and therefore exactly as much active ingredient (50 micrograms) as the company has planned for children between the ages of six and eleven.
In contrast to the Biontech vaccination, the Moderna vaccination is not yet approved for this age group.
However, the company has already tested its vaccine on six to eleven year olds and applied for an extension of its marketing authorization in Europe for this age group in November.
Ema is currently checking the submitted documents.
More than 4,700 children of that age took part in the Moderna study.
That is significantly more than in the Biontech approval study, for which almost 2,300 children between the ages of five and eleven were examined.
Some of the children in the study received two 50 microgram doses of the Moderna vaccine 28 days apart, and some received a placebo.
According to Moderna, the children tolerated the vaccine well.
The side effects observed were reported to be comparable to those seen in studies in teenagers and adults.
Most often the children suffered from headache, fever, pain at the injection site and fatigue.
They also developed "a robust antibody response," as the company announced.
On the basis of the results, it can be assumed that the children who were accidentally vaccinated in Olpe are not exposed to any greater risk and will benefit from the vaccination.
However, it is questionable to use a vaccine before independent experts have assessed the benefits and risks of the product and voted in favor of approval.
In addition, there is evidence that the Moderna vaccine can rarely cause myocarditis in adolescents and young adults.
For this reason, the Standing Vaccination Commission (Stiko) based in Germany currently only recommends the Biontech vaccine for 12 to 30 year olds, although the Moderna vaccine is officially approved for these age groups.
From a purely
legal point of
view, if in doubt, doctors can also use drugs outside of their approval - for example, if there are indications that someone would benefit significantly despite the lack of approval and no alternatives are available. At the beginning of the corona pandemic, for example, no drugs were explicitly approved for Covid-19. Nonetheless, certain remedies have been used that studies have indicated of benefit to the seriously ill.
The prerequisite for such so-called off-label use is, however, that patients are informed about it.
In addition, it is only advisable when no alternatives are available.
This no longer applies to the Moderna vaccine for children of this age group, as the Biontech vaccine is an approved mRNA vaccine for five to twelve year olds.
Last week, the Corona vaccination ordinance was changed so that the state is liable in the event of vaccination damage after an off-label vaccination.
This has long been a matter of dispute.
However, the Federal Ministry of Health confirmed on Twitter that vaccinations for under-five year olds and booster vaccinations for children are excluded from the new regulation.
A lawyer disagreed with this representation.
In the case from Olpe, however, it is not an official off-label vaccination, as the vaccinating employee did not give the Moderna vaccine consciously or for medical reasons.
The parents were not informed either.
If the children actually suffer damage as a result of the vaccination, "claims must be made against the state of North Rhine-Westphalia within the framework of official liability," said the Ministry of Health.
What are the consequences of the incident?
The district of Olpe confirmed that the incident was being used as an opportunity to review all procedures and child vaccinations.
If further incidents are discovered, the parents would be informed.
The North Rhine-Westphalian Ministry of Health pointed out to SPIEGEL that the districts and urban districts had been instructed by decree to separate the vaccination offers for children from the other offers of first, second or booster vaccinations for adults and adolescents from 12 years of age hold up.
The ministry is currently in contact with the Olpe district to investigate the incident.
District Administrator Melcher said that the Standing Vaccination Commission would be asked for a professional assessment.
The circle wants to keep in close contact with the two families affected.
He announced that vaccination appointments would in future only be allocated in such a way that only one vaccine would be used in one dose.
With material from dpa