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Introduction: Health claims data are a valuable resource for health services research, enabling analysis of the costs of hospitalizations, outpatient visits, procedures, and medications, and providing an improved understanding of the economic burden and underlying cost drivers for a given health condition. Since no recent data were available from Germany on the medical costs and clinical outcomes of Clostridioides difficile infections (CDI), this study assessed the economic burden of CDI and all-cause mortality in adults in Germany., Methods: A retrospective cohort study was conducted using a large, anonymized administrative health claims research database from Germany from which an age- and sex-representative sample of 4 million insured persons covered by approximately 60 statutory health insurances was extracted. Propensity score matching was conducted on age, sex, comorbidities, and antibiotic use to identify four matched controls (i.e., patients without CDI) for every eligible adult patient with CDI (i.e., case) in the study cohort. Costs, healthcare resource utilization, and CDI-attributable all-cause mortality were assessed., Results: Overall, there were 15,342 CDI cases in the study cohort. One-year mortality in CDI cases (45.7%) was more than fourfold that of matched non-CDI controls (11.0%). In the year following the index date, average mortality-adjusted medical costs per person-time for CDI cases were almost fivefold that of matched non-CDI controls, representing a cost difference of €31,459, mainly driven by inpatient treatment. Overall excess costs for CDI cases were estimated at approximately €1.6 billion within 1 year after diagnosis., Conclusions: CDI in Germany is associated with a high clinical and economic burden, including significantly higher mortality, costs, and healthcare resource utilization, in patients with CDI versus their matched patients without CDI. This has important implications for patients, healthcare providers, and the healthcare system., Competing Interests: Declarations. Conflict of interest: Katharina Schley, Gordon Brestrich, and Christof von Eiff are employees of Pfizer Pharma GmbH; Kirstin Heinrich is an employee of Pfizer Inc; and Jennifer C. Moïsi is an employee of Pfizer Vaccines—all of whom may hold stock or stock options in Pfizer Inc. Dennis Häckl is an employee of WIG2, which received funding from Pfizer in connection with the development of this manuscript. Dominik Obermüller is an employee of InGef, which acted as subcontractor and received funding from WIG2 in connection with the development of this manuscript. Thomas Weinke received an honorarium from Pfizer in connection with the development of the study. Ethical approval: Additional ethics approval was not required as the data were anonymized, and the study, which was a retrospective analysis of an anonymized health claims research database, complied with German data protection regulations and federal law., (© 2024. Pfizer, Inc.)

Although influenza A viruses predominate globally, influenza B viruses are responsible for a significant and often underappreciated burden. Despite this, immunity to influenza B viruses remains understudied, and there is a perception that vaccine-mediated immune responses to influenza B strains are less robust than influenza A strains. This targeted literature review examines this concept using data from pivotal phase 3 immunogenicity studies on currently licensed seasonal influenza vaccines and explores several explanations for this phenomenon, including immune exposure history, assay limitations, virus-related properties inherent to B lineages, and strain mismatch. Overall, studies demonstrated vaccines induce variable and sometimes less robust immune responses to influenza B strains; however, further studies are needed to fully confirm and understand these observations. In identifying the potential causes of variable performance of current vaccines against influenza, this review aims to guide vaccine development to enhance overall vaccine performance and reduce disease burden worldwide.

Competing Interests: Die Übersicht über die Interessenkonflikte der Autorinnen und Autoren ist im Anhang des Leitlinienreports veröffentlicht.

Introduction: Clostridioides difficile infection (CDI), as a nosocomial disease, is associated with high morbidity and mortality. Even though the incidence of CDI has been declining in Germany in recent years, the individual infection may pose a medical challenge despite therapeutic advances. The aim here is to clarify which gaps practitioners consider to be particularly serious in care and in the existing evidence base., Methods: In a moderated workshop of German CDI experts the topics considered as relevant were identified. A survey already conducted in five other countries (Australia, France, Great Britain, Canada, and Italy) was adapted and processed by 27 practitioners. During the evaluation, the topics perceived as particularly important were identified, the statements of the specialist groups were compared and changes in opinion were considered., Results: 27 fully completed questionnaires were evaluated. The need for improvement was primarily seen in the prevention of CDI recurrences (74.1%) and the treatment of recurrences (55.6%). Evidence deficits were noted in the treatment of recurrences (55.6%) and identification of risk factors for recurrences (48.1%). Improving care via fecal microbiota transfer (FMT) was named by 70.4%. For guidelines, more clarity (48.1%) and more regular updates (40.7%) were desired. For patients, better education on appropriate antibiotic use (52.0%) and choice of FMT were desired (48.1%)., Summary: The German expert view and the international assessment is similar, when asked about the need for improvement in care and evidence gaps in the treatment of patients with CDI: The focus is on prevention and therapy of recurrent CDI. The problem of access to FMT is a German peculiarity that seems to need improvement., Competing Interests: MJGTV hat Forschungsmittel erhalten von 3M, Astellas Pharma, Biontech, DaVolterra, Evonik, Gilead Sciences, Glycom, Immunic, MaaT Pharma, Merck/MSD, Organobalance, Seres Therapeutics, Takeda Pharmaceutical and Tillots Pharma, sowie Vortrags- oder Beratungshonorare von Astellas Pharma, Basilea, Bio-Mérieux, DaVolterra, Farmak International Holding GmbH, Ferring, Gilead Sciences, Immunic AG, MaaT Pharma, Merck/MSD, Pfizer, Roche, Organobalance, SocraTec R&D GmbH, Tillots Pharma. SS hat persönliche Honorare von Abbvie, Arena, BMS, Biogen, Celltrion, Celgene, Eli Lilly, Falk, Ferring, Fresenius Kabi, IMAB, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Sandoz, Takeda und Theravance erhalten HJE erhielt Referenten- oder Beraterhonorare von Astellas Pharma, Ferring Arzneimittel und Tillots Pharma. CFM hat Vorträge auf von Ferring gesponserten Symposien gehalten und hat eine beratende Tätigkeit in einem Advisory-Board von Abbvie. TW hat Vortrags- und Beratungshonorare erhalten von: Astra Zeneca, BioNTech, Boehringer Ingelheim, Falk Foundation, GSK, Moderna, MSD, Pfizer, Roche, Sanofi Pasteur und Seqirus. LvM, JO und SW haben keine Interessenkonflikte angegeben. AS hat Vortragstätigkeiten für AbbVie, Bristol Myers Squibb, Celltrion, CLS Behring, De Prom, Falk Foundation, Ferring, Janssen, Kompetenznetz Darmerkrankungen, MedUpdate, MSD, Recordati-Pharma, sobi rare strength, Takeda und Beratertätigkeiten für AbbVie, Amgen, Bristol Myers Squibb, Consal, Galapagos, Gilead, Janssen, Lilly, MSD, Repha GmbH, Roche, Pfizer, Pharmacosmos GmbH, Takeda, Tillots Pharma., (Thieme. All rights reserved.)

Background: In addition to standard vaccination for patients aged 60 and older, the Standing Committee on Vaccination (STIKO) recommends immunization against pneumococci for anyone at increased risk, including patients with chronic vaccine-relevant underlying conditions. In Germany, the Robert Koch Institute (RKI) regularly publishes vaccination coverage rates (VCRs) for these patient groups, without stratifying by other parameters. This study examines VCRs of patients with underlying chronic diseases, stratified by disease groups and entities, the re-vaccination rate, and VCRs in patients aged 60 years and older., Methods: This descriptive retrospective cohort study is based on a sample of about 4 million SHI-insured patients aged 16 years and older for the years 2014 to 2019, from the Institute for Applied Health Research (InGef) database. The sample is representative of age and sex distribution in the German population., Results: Extrapolated to the total SHI-population, the overall pneumococcal VCR in patients aged 60 years and older was 45.9 % (of n= InGef standard vaccination cohort: 1 009 763). Among all at-risk patients aged 16 years and older with chronic underlying diseases, only 17.1 % had received an indicated vaccination (InGef indicated vaccination cohort: 1 379 680). Stratified by disease entity, those with underlying pulmonary emphysema had the highest VCR, at 39.0 % (of n= 28 121). Of those who received a vaccination due to an underlying chronic disease, only 23.9 % were re-vaccinated after 6 years (InGef re-vaccination cohort: 12 328). Across all vaccination cohorts, VCRs increased with age., Discussion: The recommendations made by STIKO for pneumococcal vaccination based on age or an underlying chronic condition are not being implemented adequately in Germany. Although STIKO explicitly recommends vaccination from 60 years of age, the 60 to 64-year-old age group had a strikingly low VCR (13.0 % of n=268 862). Fewer than one in five patients aged 16 years and older with an underlying chronic condition had received the recommended indicated vaccination. To adequately prevent potential disease, higher vaccination rates should be targeted. This could probably be achieved through more stringent vaccination management, appropriate software solutions with vaccination reminders, monetary incentives for achieving higher vaccination rates and documentation of vaccination status in disease management programs., Competing Interests: S. Mihm, R. Wölle, A. Suck und T. Böllinger sind Angestellte von MSD SHARP & DOHME GmbH. R. Wölle und T. Böllinger halten Aktienoptionen von Merck & Co., Inc. Rahway, NJ, USA. D. Häckl ist Angestellter der Universität Leipzig und von der WIG2 GmbH; letztere fungierte bei der Durchführung dieser Studie als Auftragnehmer von MSD SHARP & DOHME GmbH. J. Schelling und T. Weinke erhielten Beratungshonorare und Vortragshonorare von MSD SHARP & DOHME GmbH, aber keine Beratungshonorare für dieses spezifische Projekt. Ausgewählte Inhalte der Studie wurden im Jahr 2022 auf folgenden Tagungen im Posterformat vorgetragen: 88. Jahrestagung der Deutschen Gesellschaft für Kardiologie – Herz- und Kreislaufforschung (DGK) in Mannheim; 128. Kongress der Deutschen Gesellschaft für Innere Medizin (DGIM) in Wiesbaden; 7. Nationale Impfkonferenz (NIK) in Wiesbaden. Die Empfehlung der Ständigen Impfkommission für die Pneumokokken-Impfung Erwachsene wurde nach Annahme des Manuskripts und vor Druck aktualisiert. Die STIKO empfiehlt nun den Pneumokokken-Impfstoff PCV20 für Erwachsene. Die neue Empfehlung und Wissenschaftliche Begründung sind im Epidemiologischen Bulletin 39/2023 veröffentlicht. An den definierten Indikationsgruppen für eine Pneumokokken-Impfung wurden keine Änderungen vorgenommen., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Purposes: Despite reports of a declining incidence over the last decade, Clostridioides difficile infection (CDI) is still considered the most important healthcare-associated causes of diarrhea worldwide. In Germany, several measures have been taken to observe, report, and influence this development. This report aims to analyze the development of hospital coding for CDI in Germany over the last decade and to use it to estimate the public health burden caused by CDI., Methods: Reports from the Institute for Hospital Remuneration Systems, German Federal Statistical Office (DESTATIS), the Robert-Koch-Institute (RKI), Saxonian authorities and hospital quality reports during 2010-2021 were examined for CDI coding and assessed in a structured expert consultation. Analysis was performed using 2019 versions of Microsoft Excel® and Microsoft Access®., Results: Peaks of 32,203 cases with a primary diagnosis (PD) of CDI and 78,648 cases with a secondary diagnosis (SD) of CDI were observed in 2015. The number of cases had decreased to 15,412 PD cases (- 52.1%) and 40,188 SD cases (- 48.9%) by 2021. These results were paralleled by a similar decline in notifiable severe cases. However, average duration of hospitalization of the cases remained constant during this period., Conclusions: Hospital coding of CDI and notification to authorities has approximately halved from 2015 to 2021. Potential influential factors include hospital hygiene campaigns, implementation of antibiotic stewardship programs, social distancing due to the COVID-19 pandemic, and a decrease in more pathogenic subtypes of bacteria. Further research is necessary to validate the multiple possible drivers for this development., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Introduction: Clostridioides difficile infection (CDI) is increasingly recognized as a public health threat at the community level in addition to being one of the most common causes of healthcare-associated infections. In Germany, the epidemiology of CDI is primarily informed by national hospital-based CDI surveillance. We used health claims data from Germany to obtain valuable insights on population-level disease burden and risk factors for CDI., Methods: This was a retrospective cohort study using a representative sample from the InGef research database. Overall and age- and sex-stratified CDI incidence rates were estimated for German adults from 2013 to 2017 using different case definitions (i.e., main, broad, strict), and further stratified by setting (inpatient versus outpatient). Risk factors for CDI were assessed for the 2013-2016 period., Results: The CDI incidence rate was high but declined by 15.3% from 2013 [141 (95% confidence interval, CI 137-145) cases/100,000 person-years] to 2017 [120 (95% CI 116-123)]. Annual CDI incidence rates were higher in female patients and the elderly. The most important risk factors for CDI were chronic inflammatory bowel disease [odds ratio (OR) 4.7, 95% CI 4.0-5.5], chemotherapy (OR 4.7, 95% CI 4.1-5.2), chronic kidney disease (OR 2.9, 95% CI 2.6-3.3), and ciprofloxacin receipt (OR 2.6, 95% CI 2.4-2.8)., Conclusions: Despite prevention strategies leading to declining incidence, CDI remains an important public health threat in Germany, with a high burden in the hospital setting and an outpatient epidemiology that is poorly understood. These findings, which are relevant both regionally and globally, can be used as a basis for further research on the full burden of CDI in Germany., (© 2023. The Author(s).)

Introduction: Clostridioides difficile infection (CDI) is a recognized global threat especially for vulnerable populations. It is of particular concern to healthcare providers as it is found in both hospital and community settings, with severe courses, frequent recurrence, high mortality and substantial financial impact on the healthcare system. The CDI burden in Germany has been described and compared by analysing data from four different public databases., Methods: Data on hospital burden of CDI have been extracted, compared, and discussed from four public databases for the years 2010-2019. Hospital days due to CDI were compared to established vaccine preventable diseases, such as influenza and herpes zoster, and also to CDI hospitalisations in the United States (US)., Results: All four databases reported comparable incidences and trends. Beginning in 2010, population-based hospitalised CDI incidence increased to a peak of > 137/100,000 in 2013. Then, incidence declined to 81/100,000 in 2019. Hospitalised patients with CDI were predominantly > 50 years of age. The population-based incidence of severe CDI was between 1.4 and 8.4/100,000 per year. Recurrence rates were between 5.9 to 6.5%. More than 1,000 CDI deaths occurred each year, with a peak of 2,666 deaths in 2015. Cumulative CDI patient days (PD) were between 204,596 and 355,466 each year, which exceeded cumulated PD for influenza and herpes zoster in most years, though year-to-year differences were observed. Finally, hospitalized CDI incidence was higher in Germany than in the US, where the disease is well recognized as a public health threat., Conclusions: All four public sources documented a decline in CDI cases since 2013, but the disease burden remains substantial and warrants continued attention as a severe public health challenge., (© 2023. The Author(s).)

Background: In response to the coronavirus disease (COVID-19) outbreak that unfolded across Europe in 2020, the World Health Organisation (WHO) called for repurposing existing influenza surveillance systems to monitor COVID-19. This analysis aimed to compare descriptively the extent to which influenza surveillance systems were adapted and enhanced and how COVID-19 surveillance could ultimately benefit or disrupt routine influenza surveillance., Methods: We used a previously developed framework in France, Germany, Italy, Spain and the United Kingdom to describe COVID-19 surveillance and its impact on influenza surveillance. The framework divides surveillance systems into seven subsystems and 20 comparable outcomes of interest and uses five evaluation criteria based on WHO guidance. Information on influenza and COVID-19 surveillance systems were collected from publicly available resources shared by European and national public health agencies., Results: Overall, non-medically attended, virological, primary care and mortality surveillance were adapted in most countries to monitor COVID-19, although community, outbreak and hospital surveillance were reinforced in all countries. Data granularity improved, with more detailed demographic and medical information recorded. A shift to systematic notification for cases and deaths enhanced both geographic and population representativeness, although the sampling strategy benefited from the roll out of widespread molecular testing. Data communication was greatly enhanced, contributing to improved public awareness., Conclusions: Well-established influenza surveillance systems are a key component of pandemic preparedness, and their upgrade allowed European countries to respond to the COVID-19 pandemic. However, uncertainties remain on how both influenza and COVID-19 surveillance can be jointly and durably implemented., (© 2021 Sanofi Pasteur. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Although influenza is primarily considered a respiratory infection and causes significant respiratory mortality, evidence suggests that influenza has an additional burden due to broader consequences of the illness. Some of these broader consequences include cardiovascular events, exacerbations of chronic underlying conditions, increased susceptibility to secondary bacterial infections, functional decline, and poor pregnancy outcomes, all of which may lead to an increased risk for hospitalization and death. Although it is methodologically difficult to measure these impacts, epidemiological and interventional study designs have evolved over recent decades to better take them into account. Recognizing these broader consequences of influenza virus infection is essential to determine the full burden of influenza among different subpopulations and the value of preventive approaches. In this review, we outline the main influenza complications and societal impacts beyond the classical respiratory symptoms of the disease., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JN, SSC, SIS, and BTS are employees of Sanofi Pasteur. AEM has received honoraria for lectures or advisory boards from Sanofi Pasteur, Stendhal Pharma, Roche, and Pfizer. JEM has received honoraria for participation in advisory boards or lectures and related travel support from Sanofi, and participation in data monitoring boards or advisory boards for GSK, Pfizer, Merck, and Medicago. MCN has received honoraria for lectures or advisory boards from Sanofi Pasteur and Pfizer, and research grants from MedImmune. TW has received honoraria for lectures or advisory boards from MSD, Sanofi Pasteur, and Seqirus. HY has received investigator-initiated research funding from Sanofi Pasteur, GlaxoSmithKline, Yichang HEC Changjiang Pharmaceutical Company, and Roche (Shanghai)., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Lyme borreliosis develops in 1-5% of individuals bitten by ticks, but with a diagnostic gap affecting up to 30% of patients, a broadly applicable pharmacological prevention strategy is needed. Topical azithromycin effectively eradicated Borrelia burgdorferi sensu lato from the skin in preclinical studies. We assessed its efficacy in human beings., Methods: In this randomised, double-blind, placebo-controlled, multicentre trial done in 28 study sites in Germany and Austria, adults were equally assigned to receive topical 10% azithromycin or placebo twice daily for 3 consecutive days, within 72 h of a tick bite being confirmed. Randomisation numbers, which were stratified by study site, were accessed in study centres via an interactive voice-response system, by pharmacists not involved in the study. The primary outcome was the number of treatment failures, defined as erythema migrans, seroconversion, or both, in participants who were seronegative at baseline, had no further tick bites during the study, and had serology results available at 8 weeks (intention-to-treat [ITT] population). This study is registered with EudraCT, number 2011-000117-39., Findings: Between July 7, 2011, and Dec 3, 2012, 1371 participants were randomly assigned to treatment, of whom 995 were included in the ITT population. The trial was stopped early because an improvement in the primary endpoint in the group receiving azithromycin was not reached. At 8 weeks, 11 (2%) of 505 in the azithromycin group and 11 (2%) of 490 in the placebo group had treatment failure (odds ratio 0·97, 95% CI 0·42-2·26, p=0·47). Topical azithromycin was well tolerated. Similar numbers of patients had adverse events in the two groups (175 [26%] of 505 vs 177 [26%] of 490, p=0·87), and most adverse events were mild., Interpretation: Topical azithromycin was well tolerated and had a good safety profile. Inclusion of asymptomatic seroconversion into the primary efficacy analysis led to no prevention effect with topical azithromycin. Adequately powered studies assessing only erythema migrans should be considered. A subgroup analysis in this study suggested that topical azithromycin reduces erythema migrans after bites of infected ticks., Funding: Ixodes AG., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: In times of mass tourism, traveler's diarrhea is one of the most common health problems of long-distance travel. Globally, some 40 million cases occur annually. Travellers to risk areas should therefore be comprehensively advised beforehand, as to what action to take in case of an acute traveler's diarrhea and what drugs to add to their first-aid kit. To date none, or hardly any specific studies or valid specific guidelines for the treatment of traveler's diarrhea are available for Germany., Method: Drafting a consensus paper based on results of a specialists' meeting to evaluate therapeutic options in the treatment of acute uncomplicated travelers' diarrhea. The foundation for the present consensus recommendations is current evidence on antidiarrheals available in Germany for symptomatic treatment of gastrointestinal infections, summarized in the S2k guideline for gastrointestinal infections and Whipple's disease. Further taken into account for the present consensus recommendations were Pubmed-listed publications on symptomatic treatment of traveler's diarrhea, practical aspects, and the experts' experience in travel medicine., Results and Conclusion: For the treatment of acute uncomplicated traveler's diarrhea - more than 90 % of all cases - the secretion inhibitor racecadotril is considered first choice, based on our evaluation criteria. The previously usual practice of recommending the antimotility drug loperamide as first choice should be reconsidered, in favor of the recent active ingredient racecadotril. Antibiotics should be used only in complicated cases. A large number of travelers who generally demand antibiotic therapy should be disabused of their expectations. Other therapeutic measures that are currently available for the treatment of acute diarrhea while traveling play a subordinate role.

Herpes zoster (HZ) is primarily a disease of nerve tissue but the acute and longer-term manifestations require multidisciplinary knowledge and involvement in their management. Complications may be dermatological (e.g. secondary bacterial infection), neurological (e.g. long-term pain, segmental paresis, stroke), ophthalmological (e.g. keratitis, iridocyclitis, secondary glaucoma) or visceral (e.g. pneumonia, hepatitis). The age-related increased incidence of HZ and its complications is thought to be a result of the decline in cell-mediated immunity (immunosenescence), higher incidence of comorbidities with age and social-environmental changes. Individuals who are immunocompromised as a result of disease or therapy are also at increased risk, independent of age. HZ and its complications (particularly postherpetic neuralgia) create a significant burden for the patient, carers, healthcare systems and employers. Prevention and treatment of HZ complications remain a therapeutic challenge despite recent advances. This is an overview of the multidisciplinary implications and management of HZ in which the potential contribution of vaccination to reducing the incidence HZ and its complications are also discussed.

Zostavax(®) is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During the clinical development of Zostavax, which was mainly in the US, the vaccine was administrated by the subcutaneous (SC) route. In Europe, many healthcare professionals prefer administering vaccines by the intramuscular (IM) route. This was an open-label, randomised trial conducted in 354 subjects aged ≥50 years. The primary objectives were to demonstrate that IM administration is both non-inferior to SC administration in terms of 4-week post-vaccination geometric mean titres (GMTs), and elicits an acceptable geometric mean fold-rise (GMFR) of antibody titres measured by glycoprotein enzyme-linked immunosorbent assay. Pre-specified non-inferiority was set as the lower bound of the 95% confidence interval (CI) of the GMT ratio (IM/SC) being >0.67. An acceptable GMFR for the IM route was pre-specified as the lower bound of its 95% CI being >1.4. Description of the VZV immune response using the interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay and of the safety were secondary objectives. Participants were randomised to IM or SC administration (1:1). The baseline demographics were comparable between groups; mean age: 62.6 years (range: 50.0-90.5). The primary immunogenicity objectives were met (per protocol analysis): GMT ratio (IM/SC): 1.05 (95% CI: 0.93-1.18); GMFR: 2.7 (2.4-3.0). VZV immune response using IFN-γ ELISPOT were comparable between groups. Frequencies of systemic adverse events were comparable between groups. Injection-site reactions were less frequent with IM than SC route: erythema (15.9% versus 52.5%), pain (25.6% versus 39.5%) and swelling (13.6% versus 37.3%), respectively. In adults aged ≥50 years, IM administration of Zostavax elicited similar immune responses to SC administration and was well tolerated, with fewer injection-site reactions than with SC administration., (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)