Improving vaccine supply

Current challenges and social value of vaccination prevention

Vaccinations are an effective preventive measure against infectious diseases. High vaccination rates protect various population groups from the onset of illness and serious disease progression. In addition to reducing the incidence of illness, vaccinations can lead to direct cost savings through fewer hospitalizations, doctor visits, and complications, as well as indirect savings from a societal perspective. According to the Robert Koch Institute, approximately one in five people aged 60 and over in Germany are vaccinated against shingles (Q1 2024) and around two in five against seasonal influenza (2023/24 season). The production, approval, and distribution of vaccines are subject to strict regulations. The STIKO recommendations and contract negotiations for cost coverage by statutory health insurance are often lengthy. Digitization offers potential for improving vaccine supply through electronic vaccination certificates and data-based reminder systems.
Likewise, low-threshold services, especially vaccinations in pharmacies, lead to increased vaccination rates and high levels of satisfaction among those vaccinated. Long-term societal effects are inadequately considered in the health economic evaluation of vaccines, which is why there is discussion about how a broader evaluation can incorporate the comprehensive value of vaccinations.

>> Vaccinations are among the most effective measures to protect against infectious diseases (Federal Ministry of Health (BMG) 2024a). They can specifically train the acquired immune system by mimicking an infection and can protect against severe disease progression and subsequent complications (BMG 2024b).
Vaccine types and technologies
Which vaccine is best suited to prevent a particular disease depends on the characteristics of the pathogen (BMG 2024b). Different types of vaccines and technologies are used to protect against infectious diseases. These differ, among other things, with regard to
• their components and the reaction they trigger in the immune system (BMG 2024b),
• the degree of fragmentation (Schilling 2008),
• the method of production (Leroux-Roels et al. 2011; Strugnell et al. 2011),
• the frequency with which they need to be vaccinated in order to build up sufficient protection (BMG 2024b).

Due to virus mutations, such as influenza, there are also seasonal vaccines that are adapted each season to the circulating virus variations (BMG 2024b). Despite years of research, no vaccine is yet available for many pathogens. Researchers are working on developing effective vaccines using new technologies (BMG 2024b). However, the development of new types of vaccines is a complex, time-consuming, and multi-step process (Leroux-Roels et al. 2011).
Need for high vaccination rates
Vaccinations can protect against diseases or lead to less severe courses of illness. The likelihood of infecting other people is significantly reduced. A high vaccination rate creates "community protection," which also protects those who are not vaccinated or who do not have a protective immune response (BMG 2024b). Vaccinations offer great potential for preventing infectious diseases and the associated severe courses of illness, especially for high-risk individuals such as the elderly and those with chronic illnesses (BMG 2024b; Kwetkat 2023). Furthermore, vaccinations can reduce the number of medical treatments required for severe illnesses (Deutsches Ärzteblatt 2024).
Vaccination rates
In order to implement, evaluate, and optimize vaccination programs in a targeted manner, vaccination rates in Germany are compiled and made available nationwide by the Robert Koch Institute (RKI) as part of the KV (Association of Statutory Health Insurance Physicians) vaccination surveillance (RKI 2024a). This chapter presents German and international vaccination rates using the examples of vaccinations for protection against herpes zoster (shingles) and influenza (flu).

Vaccination rates using the example of herpes zoster vaccination
Herpes zoster, also known colloquially as shingles, is caused by the varicella
zoster virus. After a person recovers from chickenpox, the virus remains in the nerve cells for life. At a later stage, the virus can reactivate and cause herpes zoster (RKI 2018a). The disease can sometimes cause severe pain in those affected (RKI 2017). Vaccination with the inactivated herpes zoster vaccine is recommended by the Standing Committee on Vaccination at the Robert Koch Institute (STIKO) as a standard vaccination for people aged 60 and over and as an indication vaccination for people aged 50 and over with an increased health risk (RKI 2018b). Since March 2019, the vaccination has been a mandatory service provided by statutory health insurance providers (RKI 2022).
While the vaccination rate was 0.7% in the first quarter of 2020, it rose slightly but steadily to 24.8% by the first quarter of 2024 (RKI 2025) (data as of April 23, 2025). The development of herpes zoster vaccination rates in Germany since the first quarter of 2020 can be seen in Figure 1.
Herpes zoster vaccination is currently recommended in 11 of the 27 member states of the European Union (EU) (Federal Foreign Office 2024; European Centre for Disease Prevention and Control 2024). According to a survey of 3,613 people aged 50 years or older in nine European countries published in 2023, the herpes zoster vaccination rate was highest in Great Britain at 23% (International Longevity Centre UK 2023). No comprehensive overview of vaccination rates in other countries, such as the influenza vaccination rates in Europe (European (EU) Commission 2024), could be identified. Herpes zoster vaccination rates have been published for various countries, but their data sources differ, making comparison difficult.

Vaccination rates using the example of influenza vaccination
The flu, also known as influenza, is transmitted through droplets or direct contact with contaminated surfaces. The most common symptoms include fever, cough, sore throat, muscle aches, and headaches. Other possible complaints include general weakness, sweating, nasal discharge, nausea, vomiting, and diarrhea. Severe cases with lung and other complications are also possible (RKI 2018c). For those at risk, the STIKO recommends an annual vaccination against seasonal influenza in the fall (RKI 2022).
According to the Robert Koch Institute (RKI), in the 2008/09 and 2009/10 seasons, approximately half of people aged 60 and older had documented influenza vaccination. Vaccination rates declined until the 2012/13 season, then remained at a level where approximately one in three people aged 60 and older received a seasonal influenza vaccination. A significant increase in the vaccination rate was observed in the 2020/21 season, followed by a downward trend in the subsequent seasons (RKI 2022). The trend in the rate among those aged 60 and over since the 2008/09 influenza season is shown in Figure 2.
Influenza vaccination rates are only recorded for people aged 65 and older in most EU countries, making a direct comparison with the data from Germany difficult (EU Commission 2024). Based on the Eurostat database (data as of December 11, 2024), Figure 3 shows the vaccination rates for people aged 65 and older in 2022 in the EU countries for which data on influenza vaccination rates are available. It is clear that the influenza vaccination rate among older people in Germany in 2022 was slightly below the average for the 27 EU countries (EU Commission 2024).
Health and economic value of vaccines using the example of herpes zoster vaccination
The evidence on the health and economic value of vaccinations is presented using the herpes zoster vaccination as an example. This includes the standard and indication vaccination with the inactivated herpes zoster vaccine recommended by the STIKO (RKI 2018b).

Health benefits of the herpes zoster vaccination
For the herpes zoster incidence in Germany, which expresses the number of new cases (Kuhn/Bolte 2024), Hillebrand et al. (2015) determined an annual standardized incidence rate between 10.4 and 10.9 per 1,000 person-years between 2006 and 2009. Outpatient and inpatient cases from routine data were considered. The incidence rate was approximately 75% higher in immunosuppressed individuals than in immunocompetent individuals (Hillebrand et al. 2015). The analysis by Ultsch et al. revealed that the incidence and the number of herpes zoster cases leading to hospitalization increase with age (Ultsch et al. 2011).
The efficacy of a vaccination is measured through controlled clinical trials (WHO 2021). The ZOE-50 study found an efficacy of 97.2% in people aged 50 and older (Lal et al. 2015). In people aged 70 and older, the results of the ZOE-70 study showed an efficacy of 89.8% in people aged 70 and older, and 89.1% in people aged 80 and older (Cunningham et al. 2016). The results of the ZOE-LTFU study, a follow-up study of the ZOE-50 and ZOE-70 studies, showed that an efficacy of 72.7% was achieved even nine years after vaccination with the inactivated herpes zoster vaccine (Strezova et al. 2022).
The effectiveness of a vaccination indicates how well vaccines protect against disease in the real world under realistic conditions (WHO 2021). A systematic literature review with network meta-analysis showed a vaccination effectiveness of 70% for the inactivated herpes zoster vaccine in immunocompetent individuals compared to no vaccination (Xia et al. 2022).
The modeling by Curran et al. shows that in Germany, around two million cases of herpes zoster in the age group 50 and older could be prevented by vaccination with the inactivated herpes zoster vaccine. In addition, according to the model, 104,586 hospitalizations, 11,154,298 visits to a primary care physician, and 248,159 complications in the remaining lifetime could be prevented. The modeling is based on the assumption that 40% of people aged 50 and older have received the first dose of the vaccine and that uptake of the second dose is 70%. The data refer to the German population in the respective age group (Curran et al. 2021).

Costs avoided by the herpes zoster vaccination
Against the background of the increase in the average number of sick days per employee in Germany (Federal Statistical Office 2025) and the associated damage to the German economy (Federal Institute for Occupational Safety and Health 2024), the relevance of disease prevention measures becomes clear.
In the modeling by Van Oorschot et al., the costs that could be saved by vaccinating with the inactivated herpes zoster vaccine per million people aged 60 and older in the German population were determined. This modeling is based on the assumption that 40% of people aged 60 and older have received the first dose of the vaccine and that uptake of the second dose is 70%. The results showed that over the remaining lifetime of the cohort (1 million people aged 60 and older), around €14.9 million in direct costs (payer perspective, discounted) and around €2.8 million in indirect costs (societal perspective, discounted) could be avoided (Van Oorschot et al. 2019).
For the cost-effectiveness of the herpes zoster vaccination in Germany, the incremental cost-effectiveness ratio (ICER) was determined as part of the modeling by Curran et al. (Curran et al. 2021). The amount of money that would have to be invested to gain one quality-adjusted life year (QALY) was calculated: For vaccination of those aged 50 and over, the value would be €30,710 per QALY, for vaccination of those aged 60 and over, €32,139 per QALY, and for vaccination of those aged 70 and over, €39,107 per QALY. Assuming a threshold of €50,000 per QALY, the authors described this intervention as cost-effective by conducting sensitivity analyses (Curran et al. 2021).
Regulatory framework

The approval of vaccines in Germany and Europe follows a strictly regulated procedure. Vaccines may only be marketed if they have been granted national approval or authorization by the European Union (EU) [Section 21 AMG]. Both efficacy and a positive benefit-risk ratio must be demonstrated [Section 25 AMG]. In Germany, the Paul Ehrlich Institute (PEI) is the higher federal authority responsible [Section 77 AMG]. For EU-wide approvals, there are the mutual recognition procedure, the decentralized procedure [Section 25b AMG], and the centralized procedure via the European Medicines Agency (EMA) (European Union (EU) 2004). After approval, the PEI continuously monitors the vaccines [Section 64 AMG].
The STIKO issues recommendations for vaccinations [Section 20 IfSG]. On this basis, the Federal Joint Committee (G-BA) decides on the inclusion of vaccinations.
in the Vaccination Directive (SI-RL)
(Federal Joint Committee (G-BA) 2024)
and thus included in the mandatory catalogue of statutory health insurance (GKV) [Section 20i of the Social Code Book V (SGB V)]. Since 2007, vaccinations have been part of the mandatory services of the GKV, guaranteeing their coverage for insured persons (Federal Law Gazette (BGBl) 2007). Contracts between health insurance funds and the Association of Statutory Health Insurance Physicians (KVen) ensure comprehensive coverage and reimbursement [Section 132e of the SGB V (SGB V)].

Factors for good security of supply
Vaccine production is a highly complex process subject to strict national and international regulations such as the German Pharmaceuticals and Active Ingredient Production Ordinance (AMWHV) (Jung et al. 2020). Because vaccines are produced worldwide in interconnected structures, stable supply chains are crucial (Grömling/Kirchhof 2020). However, around 68% of active ingredient production is located in Asia (Association of Research-Based Pharmaceutical Manufacturers 2022), which can lead to significant risks in the event of disruptions (Kagermann 2021). Germany could increase its attractiveness as a location through better industrial policy framework conditions, faster approval procedures, and access to international production networks (Kirchhoff 2021a, 2021b).
The EU also classifies complex production processes as a risk factor for supply bottlenecks (EU 2018). For example, twelve vaccines were affected by shortages in 2023 (Paul Ehrlich Institute 2024). The main reason is increased demand, which makes flexible supply difficult (Miranda-García et al. 2022). A modern industrial policy could help strengthen the resilience of supply chains (Kirchhoff 2021a).

Vaccinations and digitalization
The vaccination rate in Germany remains low among adults (RKI 2022). Approximately 72% of the population have not sought vaccination advice in the last two years (Horstkötter et al. 2017). Furthermore, a comprehensive reminder system is currently lacking (Schrörs/Zollmann 2020). The German government therefore intends to advance the possibilities of digitalization to specifically target insured persons for vaccinations (Bundestag Printed Paper 20/9046 2023). Since 2024, health insurance companies have been able to specifically point out vaccination gaps through the Health Data Use Act (GDNG).
[Section 25b SGB V]. The Digital Act (DigiG) also integrates electronic vaccination documentation into the electronic patient record (ePA) (Federal Law Gazette 2024), so that vaccination gaps can be identified and addressed early (Bitkom 2023).
The COVID-19 pandemic has highlighted the importance of functioning digital vaccination management. To date, vaccination rates have been recorded with considerable delays [Section 13 of the German Infection Protection Act (IfSG)]. During the pandemic, the Robert Koch Institute (RKI) relied on telephone surveys to obtain data (RKI 2021). A digital vaccination register could contribute significantly to rapid response to outbreaks in the future (North Rhine-Westphalia State Center for Health 2019). DigiG and GDNG enable timely vaccination monitoring (Association of Research-Based Pharmaceutical Manufacturers 2023), which will enable the implementation of health policy measures in the future based on scientifically sound and up-to-date findings (Jochimsen 2022).

Low-threshold vaccination
Low-threshold vaccination services such as those offered in pharmacies have proven effective during the COVID-19 pandemic. Pharmacists were authorized to administer COVID-19 vaccinations (Federal Law Gazette 2021). Important reasons for vaccination in pharmacies include flexible opening hours, short waiting times, and easy accessibility (Pfizer 2024). Flu vaccinations have also been available in pharmacies since 2022 (Federal Law Gazette 2022). By the beginning of 2024, over 600,000 vaccinations had been administered in pharmacies (Federal Association of German Pharmacists (ABDA) 2024). A survey found that 94% of patients would continue to use pharmacy vaccinations in the future (Werthner et al. 2025). Vaccination services offered in pharmacies are also contributing to increasing vaccination rates internationally (Rahim et al. 2024; Spinks et al. 2020).
With the draft bill for a Pharmacy Reform Act (ApoRG), the Federal
government to further expand pharmacy vaccinations in order to increase the vaccination rate
Pharmacists should also be authorized to offer additional vaccinations to people aged 18 and over (BMG 2024c). From the Federal Government's perspective, the supplementary vaccination offer has proven successful (Bundestag Printed Paper 20/12696 2024). Following the end of the traffic light coalition, it is currently unclear to what extent many legislative proposals will be pursued. Politically, it remains to be seen whether the next government will continue the expansion of low-threshold vaccination offers.
Vaccine prices in Germany
Vaccines are subject to special pricing regulations. A reference price system for vaccines was introduced in 2011 (Federal Law Gazette 2010). A core component of the EU reference price system is the comparison of the selling prices for vaccines in Germany with the average prices (reference prices) of vaccines within the European Economic Area. If the price of a vaccine per unit in Germany is higher than the reference price, the vaccine manufacturers reimburse the pharmacies for the discount they pay to the health insurance funds in the amount of the difference [Section 130a of the Social Code Book V (SGB V)]. This discount applies to all vaccinations financed by the health insurance funds. Further details are set out in the regulations of the German Association of Statutory Health Insurance Funds (GKV-SV) on the implementation of the manufacturer discount for vaccines (Federal Law Gazette 2021).
In 2023, spending on vaccinations amounted to €2.3 billion, corresponding to 4.6% of total pharmaceutical expenditure (Bundestag Printed Paper 19/13452). Previous discount agreements led to supply bottlenecks (Hillienhof 2012). To reduce the risk of supply bottlenecks (ABDA 2021), discount agreements for vaccines are now prohibited (Federal Law Gazette 2017).

Hurdles
Unlike other pharmaceuticals, there is no timeframe for the STIKO to evaluate new vaccines. For the inactivated herpes zoster vaccine, nine months passed between EMA approval and STIKO recommendation (European Medicines Agency (EMA) 2020; RKI 2018b). For the vaccine against meningococcus serogroup B (MenB), 4CMenB, it took as long as 11 years (EMA 2018; RKI 2024b). In comparison, the ACIP issued its first recommendation for the use of 4CMenB in 2015 (Folaranmi et al. 2015). The recommendation for the inactivated herpes zoster vaccine was made in the USA after just five days (Dooling et al. 2018).
According to the STIKO recommendation, it also takes time before vaccinations are available as benefits in kind. In practice, it has been shown that concluding negotiations between health insurance funds and the KVen (associated associations of statutory health insurance providers) can take several months (Pharma Deutschland e. V. 2025). Until then, the prescription must be made on a private prescription, and the medical vaccination service must be billed privately. While the invoice can be submitted to the health insurance fund for reimbursement (Kassenärztliche Vereinigung Nordrhein 2024), reimbursements increase the financial burden for insured persons (Wasem 2000).
Health insurance funds receive lump sums to promote preventive services. The amount of these lump sums is divided into three levels, with vaccinations being assigned to the lowest level [Section 15 of the Risk Structure Compensation Ordinance (RSAV)]. For an insured person who received a vaccination in a given year, a health insurance fund received an allocation of 95 cents in 2023 (Federal Office for Social Security 2024). Discussions about the morbidity-oriented risk structure compensation (Morbi-RSA) show that the morbidity orientation of risk structure compensation reduces the prevention incentives for health insurance funds (Drösler et al. 2017). There is a risk that spending on preventive measures will be reduced, as health insurance funds lose interest in prevention because allocations increase with the increasing illness of the insured (Wanek/Schreiner-Kürten 2021).

Value4money
Pharmaceutical companies finance research and development through revenue from the sale of their products (Steutel 2021). The development of new vaccines takes an average of 10.7 years with a success probability of only 6% (Pronker et al. 2013). Given the importance of vaccinations, the WHO calls for an innovation-friendly framework to encourage investment (WHO 2024). Vaccinations are considered investments in health and the economy that can enable longer and better lives for all (Steutel 2021).
According to Tunder, European reference prices are unsuitable for determining reimbursement levels because they do not allow for conclusions about benefits (Tunder/Ober 2020). Evaluations of new vaccines should consider not only costs but also comprehensive benefits. Currently, these are still insufficiently captured in common cost-benefit analyses (Beck et al. 2022). In addition to economic aspects, social and ethical effects should also be considered (Schwartz/Mahmoud 2016). Effects such as increased productivity later in life after vaccination, improved cognitive abilities, higher educational attainment, societal health benefits through community protection, and even political stability could be considered to reflect the value of vaccinations (Deogaonkar et al. 2012). The WHO adapted its guidelines in 2019 to better reflect the long-term benefits of vaccinations, as vaccines have the potential to generate many long-term health and non-health benefits (WHO 2019). Additional research will help provide decision-makers with information on the actual value of vaccinations, which may currently be underestimated in cost-effectiveness analyses (Biundo et al. 2024).
Conclusion and recommendations for action

Vaccinations are among the most effective and cost-efficient measures for disease prevention. They protect not only those vaccinated but also those around them and can contribute to the eradication of diseases. However, their benefits often only become apparent in the long term, which has so far been inadequately considered in economic evaluations. The short-term costs are offset by long-term health, social, and economic effects, which are often not fully considered (Ultsch et al. 2016). Vaccines are therefore often considered disadvantaged in health economic models (Weber et al. 2021). To capture their true value, more comprehensive evaluation approaches are needed that include a societal perspective.
Despite the high value, further challenges remain that impact the vaccination system in Germany. Regulatory frameworks, pricing mechanisms, and supply structures play a crucial role in vaccine availability. Four key strategies can be derived for a sustainable vaccination system in Germany:
1. Holistic assessment of vaccinations.
2. Strengthening public acceptance through transparent communication.
3. Digitalization as a driver for vaccination management and monitoring.
4. Expand low-threshold services to facilitate access and ease the burden on the healthcare system.
from:
Elisabeth Plath MA1 (ORCID: 0009-0008-0058-3732) /
Michael Minor MA1 (ORCID: 0009-0007-2138-0304) /
Dr. rer. pole. Christian Speckemeier1
(ORCID: 0000-0001-7507-4432) /
Prof. Dr. rer. pole. Jürgen Wasem2 (ORCID: 0000-0001-9653-168X) /
Dr. rer. medic. Anna Bußmann1 (ORCID: 0000-0002-9827-9083)

1: Essen Research Institute for Medical Management (EsFoMed) GmbH
2: Chair of Medical Management, University of Duisburg-Essen