Is the corona vaccine coming soon for children between the ages of 5 and 11? The Biontech founders Uğur Şahin and Özlem Türeci expressed their confidence in a “Spiegel” interview. Important information has not yet been published.
A corona vaccine for younger children has been waiting for a long time, now it could soon be the case: Biontech founders Uğur Şahin and Özlem Türeci announced the results of their vaccination study in the coming weeks Age group five to eleven years old. “It looks good, everything is going according to plan,” said Biontech boss Uğur Şahin the news magazine.
The study data therefore only needs to be processed for the licensing authorities, but are already available. “As early as mid-October, the first children under the age of twelve in Germany could be vaccinated with the Biontech vaccine,” it says.
What are the next steps? And what is known about the potential corona vaccine? An overview of the most important questions.
How is the current message to be assessed?
So far, only children and adolescents from the age of twelve can be vaccinated against the coronavirus in Germany. There is still no approved vaccine for younger children. The vaccine would – if it was actually approved – fill a corresponding gap, initially for children between five and eleven years of age.
However, it is not that far yet. The current announcement is initially only an announcement that Biontech will submit data from a registration study to the registration authorities in the coming weeks. Details on the effectiveness and safety of the potential vaccine have not yet been released. So it is also unclear how well the vaccine protects against corona disease in this age group.
In Europe, the study data will be viewed and evaluated by the European Medicines Agency EMA after submission. It has to recommend approval, and the EU Commission has the final say.
What is known about the potential child vaccine?
According to Biontech chief physician Özlem Türeci, it is the same vaccine that is already used in adults and children from the age of twelve – “but less dosed and less has to be filled,” she told the “Spiegel”. And: “We are already preparing the production.”
The vaccine is based on so-called mRNA technology and contains the blueprint for a virus protein. It was already expected that the dosage might be lower in children.
Will the Standing Vaccination Commission (Stiko) make a recommendation for the age group, should it be approved?
This cannot be assessed at the current time, as the data from the registration study have not yet been published. One thing is clear: Stiko will carefully weigh the benefits and potential risks of vaccination for children. The focus of this assessment will be the health benefits for the individual child.
How time-consuming this process can be was recently shown by the Stiko recommendation for children and adolescents between 12 and 17 years of age: Stiko initially only recommended vaccination under certain conditions for this age group and based on further monitoring data from the USA, in particular very rare cases of myocarditis after vaccinations, waited. After the relevant data were available, the general vaccination recommendation for the age group followed in mid-August.
How big is the corona risk for children?
In principle, children have a much lower risk than adults of getting seriously ill with Covid-19 or of dying. According to the Helmholtz Center for Infection Research (HZI) in Braunschweig, the likelihood that children in Germany will be hospitalized because of Covid-19 disease is very low as things stand. The risk that children and adolescents develop very severe courses of Covid-19, come to an intensive care unit or even die is extremely low.
The Robert Koch Institute (RKI) currently lists 23 deaths among under 20-year-olds. Many of them had serious previous illnesses. For comparison: In Germany, more than 92,500 corona deaths have been registered so far.
The President of the German Society for Child and Adolescent Medicine (DGKJ), Jörg Dötsch, said on Thursday that currently very few children in Germany are being treated in hospital for Covid-19 – which is “reassuring news”. At the same time, he warned against taking the disease in children lightly. On the basis of the data so far, it cannot be ruled out that a small proportion of children and adolescents could be affected by long-term consequences of the disease, so-called long covid.
It is already known that certain chronic pre-existing illnesses in children and adolescents can lead to somewhat more severe courses. In a press briefing by the Science Media Center earlier this week, Dötsch named trisomy 21 and severe obesity as risk factors.
The pediatrician also advised children under the age of twelve to wait for the approval data, even if they were previously ill: “We shouldn’t become overactive at this point.”
What does this mean for the potential child vaccine?
Basically, if the disease against which a vaccine is supposed to protect is usually less severe, an effective vaccine must be particularly safe so that the benefit-risk assessment turns out to be in favor of the vaccine. When evaluating the study data by EMA and Stiko, there will therefore be a special focus on the safety data of the potential children’s vaccine, but also on the observed severity of the Covid disease and possible long-term corona consequences.
Can children under the age of twelve be vaccinated with the already approved corona vaccine for adults?
No, the current vaccine is not approved for children under the age of twelve. Doctors advise against so-called “off-label use” – that is, the use of the vaccine outside of its approval.
Will a corona vaccine for even younger children follow soon?
There is still no definite answer to that. Study data on younger children aged six months and over are expected by the end of the year, announced Biontech. However, as soon as all the data are available, this vaccine candidate must first go through the approval process by the EMA.
