On the changed STIKO vaccination recommendation for 5-11 year old children without previous illnesses

Surprisingly, on May 24th, the Standing Vaccination Commission (STIKO) spoke out in favor of the one-time vaccination of healthy children between the ages of 5 and 11. A single vaccination with an mRNA vaccine, preferably with “Comirnaty”, is recommended. According to the STIKO, this vaccination recommendation is being made as a precautionary measure because a renewed increase in SARS-CoV-2 infections is expected next fall or winter. Once again, she explicitly spoke out against making children and young people's access to social participation dependent on vaccination. Federal Health Minister Karl Lauterbach then hastened to emphasize at a press conference at the German Doctors' Day in Bremen that the decision-making authority over vaccination must be left to the parents. But there are strict limits to this freedom. “In cases of conflicting attitudes between joint legal guardians in legal disputes, it can usually be assumed that the decision-making authority is transferred to the legal guardian who supports the vaccination.” The STIKO expressly refers to this decision1, issued by the Federal Court of Justice in 2017, in its recommendation. And the fact that politicians are not necessarily inclined to follow this appeal from the STIKO has already been shown by the vaccination recommendation for 12 to 17 year olds: this was ignored and the 2G rules were extended to 16 and 17 year olds.

To the history
>> In November 2021, the European Medicines Agency (EMA) recommended approval of the corona vaccine for 5 to 11 year olds. On December 17th, the STIKO recommended a primary immunization with 2 doses of the mRNA vaccine “Comirnaty” for children aged 5 to 11 with previous illnesses.
(BioNTech/Pfizer) in an age-approved formulation. STIKO justified this with their increased risk of a severe course of the Covid 19 disease. In addition, vaccination was recommended for 5- to 11-year-old children who had relatives or other contacts with a high risk of severe disease.
In December 2021, the STIKO wrote that after a careful analysis of the available data - also from the previous 4th wave of infection - there was only a low risk of severe Covid-19 disease, hospitalization and intensive care in this age group for children without previous illnesses. In Germany, for example, no Covid-19-related deaths have occurred in healthy children aged 5 to 11 during the entire pandemic so far. A general vaccination recommendation was not made due to insufficient data on vaccine safety and in view of the very low severity of the disease. According to modeling studies, only a small effect on the wave of infections prevailing at the time was expected. Exactly two years after the start of their publications, the group of authors presented their 6th ad hoc statement on SARS-CoV-2/Covid-19. Due to the characteristic of asymptomatic transmission, the epidemic has taken the expected course and made the measures based solely on containment meaningless. Other European countries have (with very few exceptions, see below) stopped all restrictions and are sticking to the combination of vaccination and increasing natural immunity.
STIKO: now vaccination for 5 to 11 year olds without previous illnesses
However, on May 24, 2022, the STIKO issued a general vaccination recommendation for all 5 to 11 year olds. This raises the question of what has changed since then and on the basis of which new data and findings the STIKO is now extending its previous vaccination recommendation to all children aged 5 to 11 years. This is particularly remarkable in view of the fact that the already low risk for this age group is likely to have decreased even further in the meantime. According to modeling by the RKI, around 80 percent have already had (at least) one contact with the virus. In any case, it cannot have been due to the available scientific evidence: The references listed by the STIKO do not reveal any data that would not have been available in January 2022, apart from the higher infectivity under Omikron with a simultaneously reduced disease burden.
On the question of the burden of disease
The scientific justification2 for the new recommendation states:
• SARS-CoV2 infection in 5 to 11 year olds is usually asymptomatic to mild.
• Less than 1/10,000 SARS-CoV-2-infected children aged 5 to 11 years without previous illnesses had to be hospitalized because of a SARS-CoV-2 infection requiring treatment.
• Both hospitalizations and Covid-19-related intensive care treatments are lowest in the group of 5 to 11 year olds compared to all other age groups. In addition, it should be taken into account that of the 103 hospitalized children in Germany recorded in the DGPI (German Society for Pediatric Infectious Diseases) register due to Corona, 57% (n = 59) were previously ill.
• Mortality was also lowest among 5- to 11-year-olds at 0.0004% compared to all other age groups. A total of 9 deaths between the ages of 5 and 11 were reported to the Robert Koch Institute, all of which suffered from serious previous illnesses - for which there was already a vaccination recommendation.
• Since the beginning of the pandemic, no fatal cases of PIMS (Pediatric Inflammatory Multisystem Syndrome temporally associated with SARSCoV-2, also: PIMS-TS) have been reported in Germany. The frequency of PIMS according to Omicron cannot yet be quantified. However, register data indicate that these are (even) rarer than under Delta.
• Long Covid often occurs in older children and adolescents and is difficult to diagnose, e.g. B. Long Pandemic.
Questionable benefit-risk assessment
To date, the STIKO's vaccination recommendations have been based on a risk-benefit assessment, which shows the benefits of a vaccination, e.g. B. in terms of avoided hospitalizations compared to the risk of side effects. This benefit-risk assessment did not allow vaccination recommendations for all 5- to 11-year-olds during Delta in January. Now a variant dominates that causes even less severe cases in children. This is not the only reason why the benefit of vaccination, especially in this age group, seems at least questionable in this country, unlike in the USA, for example, where access to medical care services is significantly more difficult for children from certain population groups and the proportion of risk patients (previous illnesses, ethnic group, etc.) is higher. For these reasons, it was already the case in the past that US studies/vaccination recommendations were not and are not easily transferrable to German conditions.
Vaccine effectiveness
The medical justification for the vaccination recommendation also states that the determined vaccine effectiveness with regard to Covid-19-related hospitalizations is not statistically significant. According to a cohort study from NY, “vaccine effectiveness against any SARS-CoV-2 infections is between 68% (start of study) and 12% (after 6 weeks)”.3
The effectiveness against infections therefore appears to decline very quickly. As far as effectiveness against PIMS is concerned, the medical justification continues, there is no data available, not even estimates. The effectiveness of vaccination in reducing the risk of transmission in 5- to 11-year-olds has not yet been examined, but "data from Denmark and Norway indicate a higher risk of transmission after Omicron than after Delta", whereby the "differences between unvaccinated and basic immunized people are for both variants are “low”. What was left unmentioned was that in the Norwegian study, contacts aged 0 to 15 years were excluded from the vaccination effectiveness calculations, as at this point children aged 12 to 15 years were only eligible for one dose of vaccination and children aged 0 to 11 years old were not even eligible for vaccination.4 In view of these data, it seems at least doubtful to what extent vaccination should be able to improve immune protection.
Surrogate parameter: possibly expected increase in neutralization capacity
The aim of vaccination is to build up a stronger basic immunity i. S. a “hybrid” immunity cited. However, this section does not refer to evidence-based study data, but rather argues with an “expected increase in neutralization capacity” and that such hybrid immunity “could potentially be used to protect children from reinfection.” However, the question arises as to why healthy 5 to 11 year olds should be protected from an infection from which, according to the data, they cannot become seriously ill under either Omicron or Delta.

Studies relate exclusively to adults
It also seems questionable how the STIKO can come to the conclusion that “a single dose for survivors” can increase immune protection in children when there is no data yet on the duration of protection after an omicron infection. The literature cited in the STIKO justification is not a study, but a letter from May 20215 (i.e. even before the delta wave), in which a total of 5 references are given that can only relate to adults. The rest of the references cited are also from 2021 and refer only to Adults and Delta.6,7,8,9,10,11,12
Vaccination of 5 to 11 year olds was a long way off at that point.
Children's immunity differs from that of adults
However, there is now some evidence that children's immunity differs significantly from that of adults. At this point, just one example is the prospective multicenter cohort study by Renk et al. pointed out, in which 328 households (548 children and 717 adults), in which at least one member had a previous laboratory-confirmed SARS-CoV-2 infection, were monitored for their serological responses 3-4 months and 11-12 months after infection. Overall, the children exposed to SARS-CoV-2 were seropositive significantly less frequently than the adults at both control times (T1: 33.76%, T2: 37.56%) (T1: 57.88%, T2: 49.56%). All seropositive participants in the study became only mildly ill or were asymptomatically infected. Children were five times more likely to seroconvert without symptoms than adults. Despite an often asymptomatic course of infection, the children had higher specific antibody levels and their antibodies persisted longer than those of adults - 96.22 % vs. 82.89 % were still seropositive 11-12 months after infection.
The authors concluded that the long-term humoral immune response to SARS-CoV-2 infection in children is robust and can provide long-term protection even after asymptomatic infection.13 Based on such results, the question arises whether one should not in children even after omicron infections, a significantly higher level of protection must be assumed compared to adults.
It is said that higher (humoral) antibody levels equate to better immune protection. However, since there is no data on the duration of protection after omicron infections, it is not clear how the STIKO can come to the conclusion that omicron infections lead to less reliable immunity in children than that with delta, especially given the fact that in which the AK level is a surrogate parameter of unclear clinical significance. However, if you define this as a vaccination goal, then further boosters could be recommended with the same reasoning. The STIKO's scientific justification also leaves unanswered the question of what happens to children who have already had multiple infections, especially those for whom these have been asymptomatic, and how the STIKO assesses the risk of an oversaturated immune system.
Protection for the future with vaccines from the past?
Now that almost 80% of 5- to 11-year-olds have had at least one contact with the pathogen, the STIKO recommends vaccination with a vaccine for immunization against the wild type, which is intended to provide better protection against known virus variants, against which in January due to marginal disease burden should not yet be vaccinated. Possibly, so on, there is also better protection against new variants.
It remains unclear how likely it is from an epidemiological-historical perspective that more pathogenic variants will emerge through mutations in the transition from pandemic to endemic. To make a comparison with the influenza vaccination: Here too, a vaccine is not proactively administered that is based on a variant that was 2.5 years old, but is adjusted annually. In this case, however, a basic immunization should take place with a vaccine that is based on the wild type from 2.5 years ago in order to protect against new variants.
Little data about possible severity
Side effects
There is also little data available on possible serious vaccination side effects in 5 to 11 year olds; The STIKO considers the data available to assess the risk of myocarditis to be insufficient. (“So far there is no sufficient global data to fully assess the risk of myocarditis, among other things. Initial reports suggest a significantly lower incidence rate of myocarditis than in adolescents aged 12 and over and young adults.”)14
This raises the question of why parents should even take the risk of side effects, whether severe or mild, given the marginal disease burden associated with a coronavirus infection for healthy 5- to 11-year-olds.
One dose – where is the scientific basis?
The approval study recommends 2 doses 21 days apart for seronegative people15, and the CDC now even recommends a booster vaccination for 5- to 11-year-olds, regardless of the fact that just as many children there may have already been infected16 and without any data available to support this could prove the benefits of such an approach. Here the children should only be vaccinated once. There are no data for such an approach and the vaccine is not approved for such a regimen. It also remains unclear on what scientific basis the interval of (at least) three months from a previous infection is justified. This time interval may have been taken into account for the duration of the recovered status, which is valid for three months in Germany. However, Germany is taking a different approach compared to other countries and it is at least questionable whether it is justified to recommend this interval between infection and vaccination based on the well-founded assumption that children develop a much more stable immunity after infection than adults.
Criteria for a vaccination recommendation not met
STIKO recommends vaccinations if they are in the public interest. At least one of the following criteria must be met: 17
• Deaths, serious illnesses and consequential damage can be avoided by vaccination (individual protection).
• The vaccination goal requires the development of herd immunity; only by vaccinating many people is it possible to protect people who cannot be vaccinated.
• Efforts are made to eliminate or eradicate pathogens.
• Vaccination can have a positive impact on the course of epidemics that can have a significant impact on public life.

There were no deaths in Germany among 5 to 11-year-olds who were not previously ill, the hospitalization rate is the lowest among all age groups, herd immunity cannot be achieved with vaccination, and the pathogen cannot be eliminated. That leaves the argument that vaccinating 5- to 11-year-olds could have a beneficial effect on the course of the pandemic, which is unconvincing in view of the fact that the vaccination has a very limited duration of action and does not confer sterile immunity.
And again there is a risk of discrimination against unvaccinated children
Of course, the STIKO cannot be held responsible for what politicians make of their recommendations. In each of its recommendations, the STIKO has also explicitly spoken out against making children and young people's access to participation in education, culture and other social activities dependent on the availability of a vaccination.
But the fact is that it was only the vaccination recommendations of the STIKO that made it possible to impose 2G/3G regulations on children and young people as well. And if the STIKO recommends reducing the indirect consequences of SARS-CoV-2 infections, e.g. B. of isolation and quarantine phases, then this is not a medical indication, but a political one. At this point it must be asked whether the STIKO believes that it can reduce the isolation and quarantine measures that are considered outdated and therefore redundant in other countries through vaccination. Trust in STIKO has suffered significantly in the last few months. But the STIKO is and remains an important institution in the context of any infection control. It would be desirable that it would also be prepared to revise decisions if there is a lack of evidence. <<