With trials still underway in Europe, and Pfizer awaiting FDA authorization in the U.S. to vaccinate under-5-year-olds, an association in Germany has decided not to wait, connecting parents who want to vaccinate their babies and toddlers with doctors willing to go "off-label" and defy national regulations.
Anja Kunz saw the COVID-19 vaccination as the only means to get out of isolation with her son Leon, who has a heart condition. The names of mother and son have been changed, to protect their identity.
Kunz had her child vaccinated when he was four years old — without assent from the European Medicines Agency. For children under five, the approval is still pending.
Begging for a jab
In February 2020, it became clear that Leon would need heart surgery. The pandemic was just picking up speed, and the doctors considered an infection too dangerous for Leon's operation to go forward. Therefore, the single mother and her son no longer met anyone and shopping came by delivery, as the mother explains in a recent interview.
Leon finally underwent surgery in the fall of 2020, but complications arose. He had to be resuscitated and, to relieve the pressure on his heart, he was put on an ECMO heart-lung machine. "I was given little hope that he would survive, but somehow he did," Kunz says.
She begged, but no one was willing.
As a result of the complications, Leon was still considered a high-risk patient, recalls Kunz, who begins to cry as she tells the story. "We isolated ourselves again, we were on our own." Leon had hardly any contact with other kids, she says, and could only talk to daycare friends on the phone.
Until the summer. "The doctors thought it was acceptable for him to go back to daycare when the infection numbers were low," she says. "I still felt uncomfortable with it, especially looking ahead to the fall, because there were no air filters in his daycare, and no testing."
The mother said she "begged" for vaccination from the doctors, but no one was willing to do it. It wasn't until August that Kunz founded a network that in November gave rise to the portal u12schutz ("U12 protection"), which Kunz put together with other parents.
More than 60 doctors willing
Luisa Martin is another "u12schutz" founder, who also asked for her name to be changed. "I was looking for a doctor in the summer to vaccinate my nine-year-old daughter," she says. "No vaccine had been approved for her yet, but my two older children had already been vaccinated at 12 and 15. It felt wrong not to protect the youngest, too." Eventually, she began identifying the first few doctors willing to vaccinate.
"We've made it a professional networking channel, with a website," Martin says. "Parents can contact us, and we support their search for doctors."
Since BioNtech/Pfizer's vaccine was approved for children five and older in mid-December, the portal has targeted parents of children under five. [In a related development in the United States, Pfizer said Tuesday that it would seek FDA approval for a vaccine for children six-months to five-year-old. Several Latin American countries have started vaccinating three and four-year-olds]
"Right now, we get 200 to 300 inquiries a day. Many are concerned about increased COVID outbreaks in daycare centers, worried that their child could suffer long-term damage after COVID," Martin says.
Across Germany, more than 60 doctors are willing to administer vaccines now. "Many also use our network because they want to remain anonymous, afraid of being attacked by vaccination opponents."
What dosage for kids under five?
The lesser risk
Since mid-December, family doctor Wolfgang von Meissner has been announcing on Twitter that children under five can be vaccinated in his practice. That was quickly followed by hate messages and death threats. Shortly before Christmas, he says, protesters with candles and torches marched in front of his practice in Baiersbronn in the southern region of Baden-Württemberg.
The family doctor vaccinates even the youngest children, because he wants to protect them from long-term effects of COVID. "In that age group, you don't really know how many are going to get it," he says. "But the vaccine in my view is clearly the lesser risk."
No immunological difference between a five-year-old and a younger child.
Von Meissner can understand why the vaccine from BioNtech/Pfizer has so far only been approved for ages five and up. "The approval studies had to be carried out quickly, so it was easier to leave out young children for the time being," he says. However, he sees "no immunological difference" between a five-year-old and a younger child. The only difference, according to him, is for newborns. Officially, von Meissner vaccinates from six months, though at the request of parents he is willing to also administer the doses from the age of three months.
So far, von Meissner has vaccinated more than 1,000 children under the age of five — some of whom traveled several hundred kilometers for the jab. Since the vaccination is an "off-label-use," a use outside official government approval, the manufacturer is not liable in case of vaccination damage. "We advise parents very thoroughly and explain the 'off-label use' and the study situation," says the doctor.
Medical law expert Andreas Spickhoff of Ludwig Maximilian University in Munich says off-label use should be based on current scientific knowledge. "The physician can also agree on different standards with the patient," he says.
The spokesman for the professional association of pediatricians and adolescents, Jakob Maske, currently considers vaccination for children under the age of five to be "medically inappropriate." In this age group there are so far very rare cases of severe consequences or long-term damage. It is true that drugs are frequently used off-label in pediatrics. "But only when a child is severely ill and he or she will otherwise suffer harm."
It's still too unclear which dosage is right for under-fives.
Jörg Dötsch, president of the German Society for Pediatrics and Adolescent Medicine, assumes that the risk of severe consequences with the Omicron variant also decreases for children with pre-existing health conditions. "One should focus on alternatives to vaccination in the absence of approval," he says. For example, adults around the child should get vaccinated and take necessary hygiene measures.
When it comes to vaccination, Dötsch believes it's still too unclear which dosage is right for under-fives. "As a human being, I can understand that parents want to have their child vaccinated out of a need for safety," says Dötsch. "As a doctor, however, I advise against it."
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