>> The SARS-CoV-2/Covid-19 epidemic has grown into a tangible crisis, at least in Germany, and the consequences of serious political mistakes are becoming apparent. Although it was clear from the start that this was an “epidemic of the elderly” and there was plenty of time to prepare for autumn and winter with well-tailored prevention programs (and to secure intensive care capacities), nothing happened – except a perpetuating series of lockdowns. At the end of 2020, the mortality rate for people over 70 was over 88% of the total Covid-19-related mortality (exactly 31,402 deaths in this age group out of a total of 35,452), and the responsibility for this does not lie in the biology of a pathogen, but rather in the responsibility of political actors.
In such a situation, it is not easy to write a differentiated statement on a topic such as vaccination, which is only accessible to a differentiated view. However, the group of authors sees an important reason for this, as it threatens to be reduced to just a small section of the topic. Just as the reception of the Corona crisis as an “apolitical” biological event that one thinks can be solved with daily numerical values represents an enormous disregard for the basic epidemiological (and historical) insight that every epidemic is a social event (with a biological trigger). The view that a vaccination campaign is ultimately just a “small prick” in the upper arm is far from reality.
The 7th thesis paper presented here is therefore based on a simple but far-reaching clarification of terms: vaccination (comprehensive development, testing and application of one or more vaccines) must be clearly separated from the vaccination campaign, which covers the entire implementation in everyday medical/nursing care and the social environment. Just as an epidemic cannot be understood from the perspective of gene probes and computer models, when it comes to establishing and managing a vaccination campaign - one of the most enormous undertakings that a society can undertake - it is not enough to have a vaccine available, but rather one must make the diverse, conflict-rich, fundamental rights-related and ethical conflicts in the organization, mediation, success control, and in general in the definition of the goal of such a campaign the subject of consideration.
Regarding the subject of the considerations, and thus the subject of the social discourse: the thesis paper has again adopted its tripartite division of epidemiology, prevention and social policy, and therefore one should perhaps start reading with the last chapter, where two contributions shed light on the socio-political background. The epidemic has led to a fragmentation of society into groups (“clans”), which primarily stabilize themselves by distancing themselves from the “outside” and have lost interest in integrating discordant, “inappropriate” opinions. The tendency becomes visible to attribute exclusive reason and scientific foundation to one side, while to the other side unreason and a penchant for conspiracy theories. The idea of science that comes into play as a closed order of facts with directly derivable instructions for action rests on a scientific
tist (and solutionist) misunderstanding of what science represents - namely, it is the constitutive principle of systematic doubt that constitutes science as a plural knowledge regime. This misunderstanding fulfills a relatively precise political function: namely that of argumentative closure and the defense or devaluation of criticism. In doing so, liberal society is depriving itself of one of its most valuable resources – critical public discourse. Caught up in the well-known cycles of media attention and the current short-windedness of political measures, science journalism reporting on the corona pandemic has rarely been free of such simplistic attributions. In practice, this narrowing and disruption of the discourse has led to a narrowing of problem solutions and a one-dimensional approach, a serious deficiency, especially with regard to the problem-solving skills that we urgently need today to overcome the Corona crisis and especially to successfully carry out a vaccination campaign .
The epidemiological situation remains depressing. As lockdowns continue, there appears to be a daily reporting rate of 20 to 30 per 100,000 inhabitants in several countries, which, assuming an unreported number of 5 in Germany, is around the figure of 1 million. corresponds to newly infected people per week. However, the risks of infection are extremely unevenly distributed; the relative Covid-19-associated mortality (based on the size of the age cohorts) is in the age cohort over 90 years in the 52nd week at 17%, between 80 and 89 at 13% and between 70 and 79 years at 6.5%, compared to only between 0.002 and 0.09% for those under 40 years old. Before individual case reports are presented again that are intended to prove the opposite: of course there are also deaths and serious illnesses among younger people, but when weighing up in an epidemic situation in which good advice is extremely expensive, the basis for action must be to start there , where the problem is – by far! – is the largest. And: if we use several million people with other diseases with a similar age distribution for comparison - there are also victims among the younger people, that constitutes (here the term would be correct) the “biology” of an (infectious) disease.
The middle and thus also the focus part of this 7th paper is again dedicated to prevention, as a continuation of thesis paper 5. The central statement is based on a unity of non-pharmacological prevention in general and specific (target group-oriented) forms on the one hand and vaccination or vaccination campaign on the other hand: “careful integration of vaccination into a comprehensive prevention strategy,” he says Subtitle of the paper. An effect can only be achieved when the approaches are combined; vaccination alone cannot achieve this, simply because of the people who either have a contraindication to the vaccination, for whom the vaccination does not result in protection or who refuse vaccination. The previous prevention measures must remain in play and be continually adapted, especially with regard to the protection of vulnerable population groups; However, they must also be coordinated with the success of the vaccination in order to avoid a loss of motivation.
This is particularly clear in nursing homes. On January 5, 2021, a cumulative 10,149 Covid-19-related deaths occurred in nursing homes alone, corresponding to 28% of all Covid-19 deaths in Germany (n = 36,537 deaths). Even with the start of vaccinations, all preventative measures must be carried out in parallel in nursing and disability facilities, in clinics and in outpatient care settings - until the relevant findings are available after vaccination. In addition to the AHA rules, this includes wearing FFP2 masks and regular testing, especially of arriving visitors, employees and service providers in the respective care area. Specific prevention measures are also described in thesis paper 5.0 and serve to prevent risks in vulnerable groups and corresponding institutions. Appropriate support for the homes with staff and financial resources is essential.
When it comes to the question of the effect of a vaccination, the effectiveness data from the approval studies are of course of primary importance. What is important is the fact that the endpoints of the present studies do not relate to infection with SARS-CoV-2/Covid-19 or infectivity, but rather to the occurrence of symptomatic disease in infected people. The approval study for the BNT162b2 vaccine from BioNTech/Pfizer was conducted with 43,548 people (21,720 verum, 21,728 placebo) and showed 162 Covid-19 symptomatic infections in the placebo group compared to 8 symptomatic infections in the verum group. When evaluating the results for those over 65, the effectiveness is still stated to be over 94 percent; for older people, the effectiveness drops, and there are too few people involved to be able to make precise statements.
The vaccine mRNA-1273 from Moderna (30,420 participants, 1:1 randomized) showed 185 symptomatic infections in the placebo group compared to 11 in the verum group; severe disease courses (e.g. with hospitalization) occurred in no patients in the verum group and in 30 patients in the active group placebo group. Information such as “95%iger protection” refers to the ratio of symptomatic courses in infected people between verum (8 or 11) and placebo (162 or 185), not to the occurrence of a pure infection with SARS-CoV-2/Covid -19 (or even the infectivity). If infected with SARS-CoV-2/Covid-19, vaccinated people have a 20 times lower risk of symptomatic Covid-19 disease than those who have not been vaccinated. The scientific comments on the approval studies focused on the presentation of effectiveness and the existing deficits in the assessment of undesirable effects, including serious allergic reactions, which make methodologically “robust” accompanying and health care research that is independent of the pharmaceutical manufacturers indispensable. The now established and proven analyzes based on secondary data from health insurance companies should be integrated as an important and available resource. The health insurance card can be a relevant aid in identifying the vaccinated person and the consequences of the vaccination that may require treatment, since the respective ICDs are documented in the health insurance data. Based on previous experience, the German medical profession has not been very willing to report side effects of medicines. This willingness to report must be made clear through persuasion and, if necessary, Remuneration can be improved.
When you turn from vaccination to designing a vaccination campaign, the primary focus is of course on organizational implementation and resolving conflicts over access and the fairness of distribution. The willingness of the German population to be vaccinated with the Covid-10 vaccine is not stable and can be influenced in the short term by emotional and media influences. A comprehensive, factual and more open information campaign is needed so that as many people as possible can make an informed decision. Vaccination is, at least in the first phase, exclusively a specific preventive measure for groups of people who are particularly susceptible to infection (individual protection).
A population protective effect (community protection) has not yet been guaranteed and should therefore not be publicly emphasized as a motivation for vaccination. In this respect, it is about the protective effect of the individual, not (yet) that of society. Vaccines may only be prioritized according to clear, scientifically based criteria. A “free market” for vaccines would extremely endanger the social consensus, especially in the early phase of the vaccination campaign, and must be prevented a priori with state resources. The highest priority groups of people require a special logistical and complex vaccination organization. One relative per resident in nursing homes must also be offered a vaccination. Further differentiation needs and a significantly higher expenditure of time are to be expected.
Another key point is education about vaccination. The individual education of those to be vaccinated is an important process and part of the necessary general information and advice for people about the vaccines. Education is part of the legitimacy of vaccination and its practice. The scope and content of information about the vaccine to be administered depends on our knowledge of its properties. The information is part of the medical treatment = vaccination on a contractual basis. Every person to be vaccinated is entitled to personal, individual information in consultation with a doctor. Information sheets/forms or videos about the vaccines cannot replace the individual conversation with the doctor, but can at best prepare for it. A waiver of personal information is only possible expressly, not just in a form. As knowledge about the properties of vaccines in practice develops, education must adapt to this knowledge. Enlightenment is a dynamic process. Not only the findings from vaccine studies are relevant, but also all new findings from the use of vaccines in vaccination practice.
The organizational implementation and the involvement of patients, for example in the context of education, are important components of the vaccination campaign. This is to be understood as a “complex multiple intervention”: the campaign itself consists of numerous individual elements and is integrated into a wide range of influencing factors (context). A vaccination campaign is not a sure-fire success; it can be damaged or even fail due to events or changes in the attitude of individuals or groups that initially appear to be negligible. In addition to the above Analysis of outcome data on vaccination protection and undesirable effects therefore requires timely accompanying research that not only takes into account biomedical factors (immunity status, diseases, development of mutations, etc.) (important as these are), but also focuses on social and adopts humanities perspectives. In the spirit of implementation research, accompanying research should be integrated into the planning of the campaign from the outset, as this should be able to identify early warning signs of disruptions to the campaign or even impending failure. This paper formulates a total of 10 core requirements for such a program.
We further present a methodological framework that helps predict the impact of a vaccination campaign. Of course, the effect of the vaccination, as described in the registration studies (and still needs to be described), is an important component, but at least as important is the accessibility of the population through the vaccination campaign and the informed decision for or against vaccination by those who do seek appropriate advice. The evaluation of the effect of the vaccines is carried out in accordance with evidence-based medicine and the principles of conducting clinical studies. The evaluation of the vaccination campaign including all environmental factors is (even) more complex. For example, “vaccination refusers” must also be included here, because every vaccination campaign must take into account the rejection of a vaccination and include this in the assessment of the overall intervention. A vaccination that appears highly effective in the study may remain ineffective in everyday implementation due to errors in communication or certain undesirable effects with the resulting high rejection rate. Instead of biomedically derived effectiveness, questions of attitude and “attitude” also play a major role here. We know very well from other contexts (e.g. hand disinfection in hospitals to prevent nosocomial infections) what central role this attitude level plays.
It is therefore desirable to plan a vaccination campaign in such a way that it is characterized by a high level of resilience, i.e. the greatest possible elasticity against disruptions and conflicts that can reduce its success. Three requirements can be derived:
A) the coherence of the individual factors must be promoted;
B) the individual factors must be aligned with a framework concept (goal and strategy);
C) an isolated success control based on individual factors does not make sense or should be avoided.

The individual factors that make up a vaccination campaign can initially be divided into 7 large groups (see box on p. 89 - full text Online-First). However, they should not be viewed as static, but rather interact, change and are subject to multiple feedback effects, which can best be described by the throughput model (see Chapter 3.4.2 - full text Online-First). The crucial task for planning a vaccination campaign is to coherently combine the individual factors mentioned and align them accordingly with the objective.
The presentation of a framework concept is the central task of political leadership. This concept must include the formulation of a goal and strategy. Among the three options of “walking through”, integration into a comprehensive prevention concept under the term “stable control” and a minimal solution (limited to risk groups), stable control stands out as the most sensible strategy. Initially, the vaccination or vaccination campaign appears to be a reinforcement of target group-oriented, specific prevention, but over time it will increasingly be understood as a general prevention measure (“for everyone”). Resolving goal and implementation conflicts is of crucial importance, especially with regard to incentives, motivation, conflicts with other social goals (e.g. data protection), the integration of non-vaccinated people and in the communication of effects and undesirable effects.
Monitoring the success of the vaccination campaign based on a single criterion (such as the vaccination rate) should urgently be avoided, as it is prone to failure and may give rise to false security. The vaccination rate can e.g. B. can be increased very quickly if younger people are vaccinated early, although this does not have a positive effect on morbidity and mortality. The more sensible alternative is to use a multidimensional score, as suggested here as an example (p. 95 – full text Online-First).
A complex multiple intervention such as a vaccination campaign is a primarily social intervention and is based on several prerequisites, of which the transparent formulation of realistic goals is the first priority. Reliable feedback on success and an understanding of leadership that sees itself as a framework for the periphery and avoids incorrect or premature determinations are further prerequisites. Outlining such strategic goals produces a clear finding: vaccinating high-risk groups will lead to a reduction in mortality and morbidity in the short-medium term, but not in reporting rates. Even assuming a high effectiveness of the vaccination on the rate of infections (the approval studies only refer to the symptomatic courses of those already infected), only around 20,000 of a total of 150,000 reported infections (13%) were prevented in the first week of March (reference week 51/2020 ), but in age cohorts over 80 years old, 3,200 of 4,700 deaths (68%) are prevented. This is a further argument for relativizing the reporting rate and the limit values derived from it in the political leadership's justification scenario. <<

1) Promise of success and at the same time a highly complex undertaking: the pair of terms vaccination and vaccination campaign stand, on the one hand, for a pharmacologically and medically determined vaccine, and on the other hand for the organization and the entirety of social questions that become relevant in the context of a vaccination. Both aspects require a different approach. The vaccination must be effective and, if possible, free of undesirable effects. The vaccination campaign represents a social and political process that must be organized in a way that is as resilient as possible. Concrete suggestions are made for this purpose in this 7th theses paper.
(2) Careful integration of vaccination into a comprehensive prevention concept: Vaccination and vaccination campaign as prevention measures form an inseparable unit with non-pharmacological prevention measures (NPI) of a general nature (contact restrictions) and specific nature (protection of vulnerable groups).
(3) At the beginning of the vaccination campaign, vaccination intervenes at the level of target group-oriented prevention, as the discussion on prioritizing the vaccine led to the conclusion that older people would be vaccinated first. As the campaign progresses and the entire population is gradually included, vaccination becomes a strategy of general prevention.
(4) The start of the vaccination campaign aimed at target groups is appropriate and necessary: Covid-19 is a disease of the elderly. In the 51st week, the weekly reporting rate per 100,000 inhabitants of the corresponding age cohort was more than 700/100,000 for those over 90 and just under 450/100,000 for those aged 85-89, while the other age cohorts were below 270/100,000 . The relative Covid-19-associated mortality based on the population of the age cohorts was 17% in the 52nd week in the age cohort over 90 years old, 13% between 80 and 89 years old and 6.5% between 70 and 79 years old, while in the Under 40-year-olds only between 0.002 and 0.09% died. Although the mortality of the three oldest cohorts was already over 85% of total mortality in weeks 41 and 42, it rose even further to over 88% in weeks 51 and 52.
(5) In addition, the general prevention strategy previously preferred by the political leadership has not been successful: the lockdown policy is ineffective, especially for the vulnerable groups. The temporary flattening of registration numbers before Christmas was observed in all age groups, except in the older age groups over 85 years. There is the paradoxical situation that a lockdown policy with high social costs is being enforced without considering other options or even thinking about an urgently needed change in strategy, even though those most affected, the older age groups and nursing home residents, cannot be protected by a lockdown.
(6) Although those who suffer from this policy, the older citizens, are urgently dependent on adequate care, there has been an unexplained loss of 6,000 reported intensive care beds (total capacity) since July 2020. The number of free intensive care beds per day increased from July to November/December. decreased by 7,000 (58%), but only 1,000 additional intensive care patients (+4.6%) were cared for daily; the further 6,000 beds that are no longer available are due to the aforementioned decline in overall capacity. There has been no national, comprehensive effort to recruit enough nursing staff and manage intensive care capacity, so triage of hospital patients is now being considered.
(7) The deficits in specific prevention have so far been particularly noticeable in the area of nursing homes. On January 5, 2021, a cumulative 10,149 Covid-19-related deaths occurred in nursing homes alone, corresponding to 28% of all Covid-19 deaths in Germany (n = 36,537 deaths). Even with the start of vaccinations, all preventative measures must be carried out in parallel in nursing and disability facilities, in clinics and in outpatient care settings - until the relevant findings are available after vaccination. In addition to the AHA rules, this includes wearing FFP2 masks and regular testing, especially of arriving visitors, employees and service providers in the respective care area. Appropriate support for the homes with staff and financial resources is essential.
(8) With regard to effectiveness, the vaccination must be analyzed according to the methodology of evidence-based medicine. In the approval study of the BioNTech/Pfizer vaccine (43,548 participants, randomized), there were 162 symptomatic Covid-19 infections in the placebo group compared to 8 symptomatic infections in the verum group. The vaccine mRNA-1273 from Moderna (30,420 participants, also randomized) showed 185 symptomatic infections in the placebo group compared to 11 in the verum group; serious illnesses occurred in no sufferers in the verum group and in 30 sufferers in the placebo group. The information such as “95%iger protection” refers to the ratio of symptomatic cases between verum and placebo, not to the occurrence of a pure infection with SARS-CoV-2/Covid (or the infectivity). If infected with SARS-CoV-2/Covid, vaccinated people have a 20 times lower risk of symptomatic Covid-19 disease than those who have not been vaccinated. The most impressive undesirable effects are the severe allergic reactions, which are, however, manageable. The number of cases is still small and there are numerous criticisms of the study design that need to be clarified as the study progresses.
(9) An effective vaccination must also exist and be implemented in everyday life in a vaccination campaign. The first phase of the vaccination campaign, namely the demanding organization of the vaccination of very old people, will have an impact on the further course of the campaign. That's why care, good information and enough time are initially more important than high or even incorrect time expectations. Pressure to succeed resulting in organizational failures is no more effective than poor communication. A good vaccination result in this important, vulnerable target group is more convincing than a quick conclusion with a lack of acceptance.
(10) Individual education of those to be vaccinated is an important process and part of the necessary general information and advice for people about the vaccines. Education is part of the legitimacy of vaccination and its practice. The scope and content of information about the vaccine to be administered depends on our knowledge of its properties. The information is part of the medical treatment = vaccination on a contractual basis. Every person to be vaccinated is entitled to personal, individual information in conversation with a doctor. Information sheets/forms or videos about the vaccines cannot replace the individual conversation with the doctor, but can at best prepare for it. A waiver of personal information is only possible expressly, not in a form.
(11) A vaccination campaign is not a sure-fire success; it can be damaged or even fail due to initially seemingly negligible events or, for example, changes in the attitudes of individuals or groups. It is therefore essential to (1) analyze the effect of the campaign right from the start with analyzes of outcome data (protection from disease, undesirable effects, etc.), including the formation of a non-vaccinated control group, and (2) through health services research approaches (e.g. surveys ) and to establish timely accompanying research through the targeted analysis of environmental factors (economics, politics, etc.). The individual measures (individual factors) that make up a vaccination campaign must be coherently linked to one another, they must be aligned with an understandable framework concept including target formulation, and an isolated success control based on individual factors makes little sense or should be avoided if possible.
(12) A meaningful framework concept as a central task of political leadership includes the formulation of a goal and a derived strategy. There are three options:
• “Move through” strategy without further consideration of the surrounding conditions,
• Integration into a comprehensive prevention concept under the term “stable control” and
• a minimal solution with priority vaccination of only risk groups.

For the group of authors, the “stable control” strategy appears to be the most sensible strategy. Resolving goal and implementation conflicts is of utmost importance, especially with regard to incentives, motivation, conflicts with other social goals (e.g. data protection), the integration of non-vaccinated people and in the communication of effects and undesirable effects.
(13) Monitoring the success of the vaccination campaign based on a single criterion (such as the vaccination rate) must be urgently avoided, as it is prone to failure and may give rise to false security. The use of a multidimensional score is recommended here, taking into account utilization (e.g. vaccination rate), impact, complications, compliance, implementation in the organizations and the attitude of management (e.g. surveys). Such a score can help to identify weaknesses in the campaign early on and take countermeasures in a timely manner.
(14) Reliable feedback on success is a crucial parameter for the success of a vaccination campaign. A rough outline shows the clear finding that vaccination of high-risk groups will lead to a reduction in mortality and morbidity in the short to medium term, but not in reporting rates: Assuming a high effectiveness of the vaccination on the rate of infections (the approval studies only refer to the symptomatic courses of those already infected), only around 20,000 of a total of 150,000 infections were reported in the first week of March (13%), but in age cohorts over 80 years 3,200 of 4,700 deaths (68%) prevented. This represents a further argument for relativizing the reporting rate and the limit values derived from it in the justification scenarios of the political leadership.
(15) Danger from groupthink in closed communities: In times of complex dangers, great uncertainty and high dynamics - such as those caused by the corona pandemic - people are tempted to reach for simple and quick solutions. You avoid complicated and lengthy discussions about the right goals and paths. Instead of relying on the competition of arguments and problem solving, archaic mechanisms are currently being activated - often unconsciously - and group formation and group thinking occur. There is a risk that relatively closed communities (clans) will emerge that separate themselves from one another and are polar opposites of one another. This tendency towards polarization makes the urgently needed discourse about good solutions to the Corona problem more difficult, is prone to errors and damages the idea of an open society.
(16) Preserve the political control function of a critical public: The public discussion about the appropriate way to deal with the virus is characterized by camp thinking and the tendency to devalue dissenting opinions. Such devaluations regularly refer to the findings of “science” that supposedly provide very clear guidelines for action. In doing so, they tend to suppress what science is at its core: namely, systematic doubt, skepticism as a method and the plurality of disciplinary perspectives. It must be a matter of not shortening the debates in a “scientist” way, of preserving the political control functions of a critical public and of freeing political measures from the one-sided fixation on incidence.