Vaccination for small children in Germany off-label possible – SWR Aktuell

Vaccinating every child under the age of five – the head of the professional association of paediatricians, Lothar Maurer, does not believe in that. It’s always a risk assessment. He himself vaccinated six children under the age of five “off-label” in his practice in Frankenthal. So far, however, these have only been small, high-risk patients with trisomy 21 or heart defects.

1,945 daycare children infected in RLP

The Omicron wave has been rolling through the kindergartens since the Christmas holidays and hasn’t died down. The Rhineland-Palatinate Ministry of Education reported at the end of January 1,945 infected daycare children. That is almost 1.2 percent of all daycare children in the country. “The decision to have your child vaccinated is a very personal one and rests with the parents. The vaccination itself is at the discretion of the paediatricians,” says the Rhineland-Palatinate Ministry of Health.

The paediatrician Benedikt Fritzsching from Heidelberg points out in an interview with SWR Aktuell: “Many parents basically want to protect their children from infection, but you have to say: The vaccinations do not protect much against an infection, but rather against a severe course. “

PIMS only rarely the result of a corona infection in children

Children rarely develop after a corona infection according to the Robert Koch Institute (RKI) the so-called Pediatric Inflammatory Multisystem Syndrome, PIMS for short, a severe inflammatory reaction. Most of these children require intensive care. According to the RKI, however, the clinical picture is usually easily treatable, and the long-term prognosis for children with more complicated courses is unclear. No deaths are known from Germany so far.

Doctor with long-Covid cases advises vaccination

According to the RKI, children and young people can also suffer from health problems Long-term consequences of Covid-19 disease to be affected. However, it is still unclear to what extent and how often children and adolescents are affected.

In Rhineland-Palatinate, small long or post-Covid patients can do rehabilitation in the gemstone clinic in Hunsrück. The medical director, Edith Waldeck, mentions shortness of breath and fatigue syndrome, an exhaustion syndrome, as frequent symptoms of her patients. She strongly recommends vaccinating children – including those under five. “Yes, we are always a little behind on everything and at a later point in time we realize that it is good that we are vaccinating these children,” she says.

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BioNTech/Pfizer relies on three doses of the vaccine for under-fives

Pharmaceutical companies BioNTech and Pfizer have one on Tuesday Emergency approval for their corona vaccine applied for in the US for children under the age of five. The series of vaccinations for babies and young children is to include a total of three doses. According to the first study data, although two doses were sufficient for children aged six to 24 months, they did not produce sufficient efficacy in children aged two to four.

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No comparable application submitted to the EU authority EMA

The current application from BioNTech/Pfizer in the USA initially includes the approval of the first two vaccine doses, the dose of which is one tenth of the adult dose – i.e. 3 micrograms of mRNA. Data on a third dose of vaccine, to be given at least eight weeks after the second dose, are expected in the coming months. These should then be submitted to the US regulatory authorities. The companies did not initially submit a comparable application to the EU medicines authority EMA.

The respective paediatricians decide on the dosage of the vaccine in the “off-label” area in Germany. Pediatrician Maurer sees 3 micrograms as too little. He therefore administered 7.5 micrograms twice or 10 micrograms as with the children from the age of five. A spokeswoman for Initiative U12Schutz.de, which arranges “off-label” vaccination offers for children under five in Germany, reports that in the past two vaccination doses of 5 micrograms were often administered, but now three vaccination doses of 3 micrograms are often used.

No serious off-label vaccination events reported

The Paul Ehrlich Institute (PEI), the Federal Institute for Vaccines, has no information on how many “off-label” vaccinations take place in Germany. In the Institute’s next safety report on the approved COVID-19 vaccines, a chapter on “off-label use” in U5 children is planned. So far, however, no serious events have been reported to the institute, according to a spokeswoman.

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