Green light to vaccinate children, but Stiko is taking his time again

Berlin. With the increase in coronavirus cases in Germany, especially among schoolchildren, vaccinations for children aged 5 to 11 are within reach. The European Medicines Agency (EMA), Thursday, gave the green light to approve the Biontech / Pfizer (Comirnaty) vaccine in the age group. Officially, the EU Commission has yet to approve. The most important questions and answers about childhood vaccinations.

Stiko took three months to recommend the vaccine to those over 12 years old. Photo: shutterstock

Is the pediatric vaccine different from the one already available?

Yes, young children get only a third of the injected dose compared to the 12-year-old, which is 10 mcg instead of 30 mcg. Otherwise, the procedure is the same for a large volume: two injections are given in the upper arm and this is at intervals of three weeks.

How well does the vaccine work?

An evaluation published in the New England Journal of Medicine evaluates the Biontech/Pfizer study. The conclusion is that vaccination is safe and effective. The effectiveness of vaccination was estimated at 90.7 percent: three of the children vaccinated for the study developed Covid-19 during the observation period – in the control group, which received only the placebo, there were 16. Serum.

How bad are the side effects?

The study authors saw “favorable safety profiles” and “no serious side effects associated with the vaccine.” Only ‘mild and temporary reactions’ such as fever, piercing pain, fatigue or headache were recorded. The picture is similar to that of the elderly who have been vaccinated. According to the authors, the three most serious injuries during the observation period, such as a broken arm, were not related to vaccination. Myocarditis, which occurred in a large number of children aged 12 years and over after vaccination, was not found in this relatively small group of people.

What does the moving average ever say?

It concludes with the data that the benefits of the vaccine outweigh the risks, especially in children with pre-existing conditions that increase the risk of severe Covid 19 cycles. The decision does not mean that vaccinating children is now recommended either. The EMA asserts that this is a matter for national governments or health authorities.

What next in Germany?

Many pediatricians are guided by the vote of the Permanent Immunization Committee (Stiko), which is still pending on the vaccination of children. “We advocate that you wait and see what Steko has to say,” said Jacob Maske, a spokesman for the Professional Association of Pediatricians. He and other experts anticipate that there should initially be a Stiko recommendation for children with pre-existing illnesses and critically ill relatives — not a general recommendation. However, this does not explicitly mean that vaccination is not possible after medical information and if the child or legal guardian so desires and before taking the risk, the German Society of Pediatrics and Adolescents stressed on Thursday.

What are Stiko’s concerns?

“Consent is something very different from a vaccination recommendation,” Stiko member Fred Zepp confirmed. To gain approval, it must be demonstrated that the vaccination triggers a protective antibody response and that it has not had any severe undesirable side effects in the test subjects. “What you don’t see in the consent study are risks that occur less than would be statistically expected in such a small group.” If only a few children are vaccinated, then very rare side effects cannot be identified, which, for example, occur only in 10 cases out of 100,000. Stiko is also interested in obtaining data on rare vaccination complications from other countries. This may be the USA, Canada and Israel, where the campaigns have already begun.

What are the risks of children contracting Covid-19?

For healthy children it is relatively low. They were indeed infected, but the fact that they were seriously ill was the absolute exception, a spokesperson for Musk’s pediatrician confirmed. So the assessment of the risks and benefits of a vaccine should be different for children than for adults: “Because the risk is so small, the benefit must be very large.” Therefore, more stringent criteria should be applied to potential side effects. “When the disease burden is very low, vaccination should be safer.”

However: The Robert Koch Institute (RKI) warns that severe illness, death and long-term consequences of COVID-19 can also occur in children. However, it is not yet possible to clearly assess the extent of the health consequences. “As long as this important question is not clarified, children should not be unnecessarily at risk of infection,” says RKI.

When will Steko decide?

The committee wants to make its recommendation before the end of the year, “if possible before delivery of the pediatric vaccine to federal states begins,” Stiko President Thomas Mertens said recently. This was announced by Acting Federal Health Minister Jens Spahn (CDU) on December 20. In the first delivery, 2.4 million doses of the vaccine will be made available.

Can pediatricians vaccinate children under 12 in advance?

Yes, it is possible and has already happened, but it is rare. “It’s a free medical decision,” Maske said. The technical term for this is off-label use. The vaccine that is already available is split up by the doctor as planned in the approval study. Musk said Thursday’s EMA decision does not change anything about the off-label situation. So doctors are not expected to offer this now on a large scale – instead, one will wait for a special children’s vaccine to be delivered before Christmas. “We also don’t anticipate that there will be a big race for practices.”

How is the mood among parents?

There are a number of parents who urgently want their children vaccinated. There are several reasons for this: for example, your previous illnesses or a child’s past illnesses, concern about the possible consequences of a corona infection or a desire to enable children to have a largely normal school and social life. Some parents are looking for doctors willing to give off-label vaccinations in their own lives. On the Internet, a volunteer initiative offers parents the opportunity to find doctors who are willing to vaccinate.

There are also parents who generally refuse to vaccinate their children. For example, because they are ashamed of the potential risks of vaccination or consider COVID-19 in children to be harmless. If parents disagree about vaccination, they can seek advice from the Youth Welfare Office. In principle, it is also possible to obtain a court decision.

Can childhood vaccinations make a breakthrough in the fight against the epidemic?

This is questionable – even if the vaccination rate in Germany is likely to continue to rise. Zepp, a Stiko member, said it’s important to remember that a big part of the problem is unvaccinated adults. “We have to be careful not to have another discussion by proxy at the expense of children. The most important measure to beat the epidemic remains unchanged, to protect as many as possible, ideally all adults through vaccination.” Because unvaccinated older people in particular have Greater risks of needing an intensive care bed in case of infection – only in the group over 60 years there are more than three million.

However: Stiko also rejected a recommendation to vaccinate people over 12 years old in June, even though the age group has long been vaccinated in other countries. Stiko didn’t issue a recommendation until August. News4teachers / Articles from dpa

Ex-Stiko member demands: Stay away from compulsory masks in schools – to quickly infect students!


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