Vaccination for children
between the ages of 5 and 11

According to figures issued under Germany's Infection Protection Act (IfSG), the hospitalisation rate among 5 to 11-year-olds is 0.2%. COVID-19 hospitalisation figures are of limited use since they do not distinguish between people who are hospitalised because of a coronavirus infection and those who happen to test positive after being hospitalised for some other condition. To make the figures more accurate, a number of different data sources were combined. The results for 5 to 11-year-olds without pre-existing conditions who catch COVID-19 show that fewer than 1 in 10,000 require hospital treatment for COVID-19 disease. Overall, the 5 to 11-year-old age group had the lowest frequency of hospitalisations and ICU admissions of all paediatric age groups. Based on these results and the IfSG figures, it is reasonable to assume that the severity of COVID-19 disease is significantly lower in the 5 to 11-year-old age group than in the population of infected individuals as a whole.

Since the vaccination rates for children between the ages of 5 and 11 are lower, infections are a more frequent occurrence in this age group. The Omicron variant is particularly contagious, even for children. However, there are currently no indications that children infected with Omicron are more likely to become seriously ill.

Paediatric Inflammatory Multisystem Syndrome (PIMS) is a multisystem inflammatory condition that can occur in children a few weeks after they get the virus. The likelihood of getting PIMS does not depend on the severity of the infection; in other words, it may occur even after a mild case of COVID-19. The main symptoms are fever, abdominal pain, tiredness and weakness. Recent data from the US indicates that paediatric COVID vaccination not only provides protection against COVID-19 itself, but also against the occurrence of PIMS subsequent to a COVID infection. A total of 54% (375/698) of the PIMS-TS cases reported to the registry of the German Society for Pediatric Infectious Diseases (DGPI) over the course of the pandemic were 5 to 11-year-olds. Half of these children required intensive care and 4% required invasive ventilation; none of them died. Only a few PIMS-TS cases have been reported since the Omicron variant became dominant, despite the high number of COVID-19 infections.

We currently have relatively little data, and there is still no generally accepted definition of long COVID in children. There is no definite evidence that children are at higher risk of long COVID. Longer-term physical health effects have rarely been observed in children, and are most likely to be recorded after cases of PIMS. The primary focus is on the psychosocial consequences of COVID-19, which are complex and difficult to assess. The symptoms are very variable (e.g. exhaustion, insomnia, poor concentration, headaches, depression) and may last for weeks or months. Studies including control groups have revealed a slight difference in symptoms between children with and without a history of SARS-CoV-2 infection.

On 25 May, 2022, the Standing Committee on Vaccination (STIKO) modified its vaccination recommendations for 5 to 11-year-olds; it now recommends a single dose of an mRNA vaccine approved for this age group (preferably Comirnaty, 10 μg) for all previously unvaccinated, healthy children in this age group. There are various reasons for recommending vaccination of healthy children aged 5 to 11. These include building more robust immunity against SARS-CoV-2, which should help protect against infection or disease involving new virus variants or subvariants; preventing the rare occurrences of severe COVID-19 disease, hospitalisations and other potential complications; and reducing the indirect consequences of SARS-CoV-2 infections such as periods of isolation and quarantine.

The goal of this initial single shot of the vaccine is to build up the best possible immune basis in the child, since estimates suggests that over 80% of children in this age group have already been infected with the SARS-CoV-2 virus. If the number of COVID-19 infections starts to increase again, experts will reconsider whether it might be necessary for all children to get a second shot and/or a booster.

STIKO recommends a primary course of two shots for healthy children who have relatives or other contacts who are at high risk of severe COVID-19 disease or who cannot themselves be sufficiently protected by a single shot of the vaccine.

For children with pre-existing conditions, the recommendation continues to be that they should receive a primary course of two vaccinations followed by one or two booster shots.

Comirnaty (10 µg) is the preferred choice of vaccine for children between the ages of 5 and 11. Spikevax (50 µg) can also be used for children aged between 6 and 11. A review of the current data indicates that both Comirnaty (10 μg) and Spikevax (50 μg) are generally well tolerated in this age group and that there are no safety concerns. All experience to date in administering Comirnaty (10 μg) suggests that the vaccine-attributable risk of myocarditis is significantly lower in 5 to 11-year-olds than in adolescents and young adults. In terms of assessing the risk of myocarditis in this age group after administering Spikevax (50 μg, approved children aged 6 to 11), the only data available so far is that obtained from the study used as the basis for approving the vaccine. STIKO therefore recommends that 5 to 11-year-olds should preferably be vaccinated with Comirnaty.

No. The vaccine dose for children aged between 5 and 11 is lower (only a third of the active ingredient used in the adult vaccine in the case of Comirnaty, and half in the case of Spikevax).

On 25 May, 2022, STIKO modified its vaccination recommendations for 5 to 11-year-olds; it now recommends a single dose for all previously unvaccinated, healthy children in this age group.

There are some key risk factors and/or pre-existing conditions that make it advisable for the child to receive a complete primary course of vaccination plus boosters. These include, for example: tumour, severe or uncontrolled asthma, obesity, cardiovascular disease, diabetes, hypertension, Down syndrome, heart defect with pulmonary hypertension and various other rare diseases. An overview can be found on page 9 of the Epidemiological Bulletin dated 18 August 2022

Vaccinated children and adolescents may experience common reactions to vaccination, most of which resolve within one to three days with no long-lasting effects. These include pain at the injection site, fever, chills and headache. Such reactions to vaccination are also commonly observed in clinical studies on adults, though observations so far suggest they are usually less severe in children.

In the US, some 9 million children aged between 5 and 11 have already been vaccinated with the BioNTech/Pfizer paediatric vaccine. Reports so far show that severe side effects are very rare. According to the Vaccine Adverse Event Reporting System (VAERS) used in the US to report side effects of vaccination, there were 12 confirmed cases of myocarditis in this age group out of approximately 9 million vaccinations, and all of those cases were mild. Other severe side effects have been reported even less frequently.

In summary, the available safety data indicates that the risk of myocarditis in the 5 to 11-year-old age group is significantly lower than that of adolescents and young adults. The risk has been reduced still further by leaving a longer period between doses. No new safety concerns were identified for Comirnaty based on the available data. Data based on administering Spikevax is not yet available, so it is still too early to make a conclusive assessment of its safety.

Long-term or delayed effects are not to be expected due to the vaccine’s mode of action. The vaccine is completely broken down in the body after a few hours or days. If they do occur at all, adverse side effects occur shortly after vaccination. However, very rare side effects of vaccinations are sometimes only discovered later on because they only become apparent when a sufficient number of cases have been studied: if an adverse reaction occurs in only one in 50,000 cases, it will not be detected if only 5,000 cases are investigated (as in the study used to approve the paediatric vaccine, for example). The data that is now available on the approximately 9 million children that have been vaccinated in the US alone does not so far suggest any increase in the incidence of any particular side effects in children.

No. It has been proven that vaccination has no negative impact on the fertility of boys/men or the ability of girls/women to conceive. This also applies to boys and girls before and during puberty.

Yes, the Omicron variant, in particular, has demonstrated the ability to evade vaccine-induced immunity. However, there are some indications that vaccination reduces an infected individual’s viral load. A vaccinated person is less likely to infect others if they themselves get infected. Additionally, vaccination protects against severe disease and complications.

No, it doesn’t make sense to wait for a paediatric version of the vaccine to be approved. Although a vaccine tailored to the Omicron variant has already been approved for adults, it is likely to be some time before this is made available for children. The risk of a child becoming infected before a modified vaccine becomes available is very high, especially given the spread of the Omicron variant.

New inactivated vaccines are initially approved for adults; they are only approved for younger children in a later step once the appropriate study results are available. The protein-based vaccine Nuvaxovid (Novavax) is currently approved for people aged 12 and over. It is unlikely that approval for children will be granted in the short term and that we will have access to the same kind of comprehensive data on safety for children as we already have for the BioNTech/Pfizer paediatric vaccine that has already been approved. Based on the evidence available so far, it does not appear that inactivated vaccines offer any advantages in terms of efficacy or safety compared to the BioNTech/Pfizer paediatric vaccine that has already been approved. There is also a high risk of a child becoming infected with COVID-19 before the inactivated vaccine is approved for this age group. So there is no reason to wait for the approval of an inactivated paediatric vaccine if you have already decided in principle to get your child vaccinated. It is important to note that the approved mRNA vaccine is not a live vaccine either, since it uses a pathogen that cannot replicate. Instead, the vaccines that work on the basis of the mRNA principle combine the advantages of inactivated and live vaccines without any of the essential disadvantages.

It can be assumed they are immune if the infection was recent. If some time has passed since the infection, immunity may have weakened, so getting vaccinated makes sense in this case, especially for children with pre-existing conditions. The recommended interval between infection and vaccination is at least three months, ideally six months.

Children have a right to take part in decision-making, and should be involved in decisions that affect them, depending on their level of maturity. However, the responsibility for deciding whether to get a child vaccinated lies with the parents, not the child. Materials that are specifically designed to answer questions about vaccination in a way that’s easy for children to understand can be found on various websites including the German Federal Ministry of Health website, the logo! website and here in the Downloads section.

Paediatricians are the first point of contact if you want to get your child vaccinated. Many paediatricians will vaccinate children aged between 5 to 11 – as recommended by the Standing Committee on Vaccination (STIKO) – if parents wish to have their child vaccinated. There are also opportunities to get children vaccinated at vaccination support centres or as part of vaccination campaigns. To find out where vaccinations are available, check out the information on dranbleiben-bw.de; you can also search specifically for vaccination clinics and campaigns specifically aimed at children. Vaccination appointments in Baden-Württemberg can also be booked online at www.impftermin-bw.de and by calling 0800 / 282 272 91.

Yes. Children can only get vaccinated with the consent of their parents or guardians; once children reach adolescence (approx. 14 years old), there may be certain cases in which the child can make their own decision. If both parents have joint custody, both parents must give their consent. A second signature is not required for single parents or guardians.

A digital vaccination certificate is issued for each vaccination. Parents can download this onto their smartphone and view it in the Corona Warn app or the CovPass app, though the digital vaccination certificate with a QR code can also be used on paper. Vaccination cards also available, for example from pharmacies (for a fee). For children who do not have a mobile phone, this offers another option for them to carry their vaccination certificate with them.

No. When it comes to getting children vaccinated, what matters most is what’s best for the child. The legal requirements ensure that children have access to facilities and events, for example, even if they are unvaccinated.