Biontech / Pfizer vaccine – EMA recommends corona vaccine for children aged five and over

On November 25, 2021, the European Medicines Agency (EMA) gave the green light for the use of the Biontech vaccine in children under the age of 12 (imago images /

There are around five million children in Germany in the age group from five to eleven for whom the EMA has now approved the corona vaccine. There are around 750,000 per year. The managing health minister Jens Spahn (CDU) expects that the first around two million doses for children’s vaccinations will be delivered shortly before Christmas. An official recommendation from the Standing Vaccination Commission (STIKO) for the immunization of five to eleven year olds is still pending.

In the approval studies, the vaccine from Biontech was tested in a lower dose on almost 2,300 children in the age group five to eleven years. A lower dose means that the children only received a third of the amount of vaccine that is given to children and adolescents from the age of twelve. Apparently that’s enough, because this dose protected those under twelve from infection just as well as those over the age limit. The side effects are also comparable to those of older children, it is said. Some children had headaches and felt weak – side effects very similar to those that occur in adults. According to the study, there were no serious side effects.

More about corona vaccinations

Pediatricians expect that the STIKO’s recommendation will initially only be given to children who are at increased risk of a severe course of Covid. For example because they are chronically ill or very overweight. Later, when you have already gained a little more experience with the vaccination, the STIKO should then extend the recommendation to all five to eleven year olds.

The primary purpose of the pivotal studies is to assess the safety of a vaccine. In the study on which the EMA recommendation is based, however, the vaccine was only administered to fewer than 3000 children. There are too few participants to discover very rare side effects. Since the beginning of the worldwide corona vaccination it has been shown: some side effects of the vaccine were only registered after several million people had been vaccinated. However, the results of the present study are sufficient for the vaccine to be approved.

However, when it comes to a vaccination recommendation, the STIKO weighs up differently. The focus is on the individual benefit of a vaccination. If this outweighs the possible risks of vaccination, the STIKO recommends the vaccine. In order to be able to assess this, the committee members look at all studies and data that are already available on the vaccine. The experiences from other countries are extremely valuable. The Biontech vaccine has already been inoculated to more than three million children under twelve in the USA. Vaccinations for younger children have also started in Israel and Canada.

The President of the German Society for Children and Adolescent Medicine, Jörg Dötsch, assesses the risk for small children of getting seriously ill with Covid as still low. At the moment, paediatricians would be more concerned about another virus: the RS virus, which leads to serious illnesses in some children.

Parents should consider for themselves whether they want to protect their child from infection or whether, in their opinion, the possible risks of vaccination outweigh them. An argument in favor of immunizing children could also be the protection of a family member who is at increased risk of a severe course of Covid.

Under no circumstances should it be about vaccinating children under the age of twelve to achieve a higher vaccination rate in society, stressed Dötsch: It is not the task of children to protect adults from infection, rather the problem is the unvaccinated adults.

It’s hard to tell. Dötsch reports that he received daily emails from parents who worry that their children could get Covid. It is also known that some parents had their children vaccinated “off-label”, i.e. before the EMA recommendation and the official approval of the vaccine for children under twelve years of age.

The COSMO study at the University of Erfurt, which among other things examines vaccination motivation in Germany on the basis of random samples, provides a clue. In this survey at the beginning of November, 40 percent of parents said that they would very likely have their children vaccinated. 20 percent were still unsure, and another 40 percent of parents said that they are unlikely to have their children vaccinated or probably not.

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